Data / Medical devices / United States / Zimmer, Inc.
Zimmer, Inc.: FDA-registered device maker in Warsaw, IN, United States, 330 510(k) clearances and 1 PMA approval
Zimmer, Inc. is registered with the FDA (registration 1822565) in Warsaw, IN, United States. It lists 141 device types. The FDA files 330 510(k) clearances and 1 PMA approval under its listings, the newest dated September 24, 2026. 267 recall events name it as the recalling firm (3 Class I). Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 1822565
- FEI number
- 1000220733
- Address
- 1800 W. Center Street, Warsaw, IN, United States, 46580
- Owner or operator
- ZIMMER, INC. (1822565)
- Roles
- Contract manufacturer, Manufacturer, Manufacturer for export, Repackager or relabeler, Specification developer
- First device listed
- January 6, 1978
- Registered through
- 2027
- Brand names listed
- (Bigliani/Flatow) Shoulder, (Ti-6Al-4V Alloy, CP Grade Titanium, 3 Dose Compact Mixer, 3.5MM PLATES AND SCREWS-4936 PLATES, 4835 SCREWS, APR & APRII Press-Fit Universal Hip, APR Acetabular Insert, APR Hip Sys & Natural-Hip for Uncem and more
Devices it lists
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance. Newest 100 of 330.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| September 24, 2026 | K262955 | OsseoFit Stemless Shoulder System | PKC | Substantially Equivalent | Zimmer, Inc. | accessdata.fda.gov |
| September 23, 2026 | K261453 | G7® Acetabular System | LPH | Substantially Equivalent | Zimmer Biomet | accessdata.fda.gov |
| June 16, 2026 | K261683 | Augment Off-Axis Instrument System | PHX | Substantially Equivalent | Zimmer, Inc. | accessdata.fda.gov |
| June 16, 2026 | K260831 | Z1 Hip System | LZO | Substantially Equivalent | Zimmer, Inc. | accessdata.fda.gov |
| May 28, 2026 | K251840 | Zimmer® Persona® Personalized Knee System | MBH | Substantially Equivalent | Zimmer, Inc. | accessdata.fda.gov |
| April 27, 2026 | K260182 | Avenir® Müller Stem; Avenir Complete Hip System | LZO | Substantially Equivalent | Zimmer, Inc. | accessdata.fda.gov |
| April 13, 2026 | K253592 | Zimmer Biomet Reverse Shoulder Prosthesis (Alliance Humeral Bearings, Identity Humeral Trays, Comprehensive Reverse Humeral Trays, Comprehensive Reverse 32mm Glenospheres and Adapter) | MBF | Substantially Equivalent | Zimmer, Inc. | accessdata.fda.gov |
| March 12, 2026 | K253566 | Affixus Retrograde Femoral Nailing System | HSB | Substantially Equivalent | Zimmer, Inc. | accessdata.fda.gov |
| March 9, 2026 | K253189 | Persona the Personalized Knee System (Persona Porous Plasma Spray PPS Femurs) | MBH | Substantially Equivalent | Zimmer, Inc. | accessdata.fda.gov |
| February 4, 2026 | K252623 | G7® Revision Acetabular System | LPH | Substantially Equivalent | Zimmer, Inc. | accessdata.fda.gov |
| August 11, 2025 | K251098 | Identity Revision Humeral Stems | MBF | Substantially Equivalent | Zimmer, Inc. | accessdata.fda.gov |
| July 31, 2025 | K243571 | Trabecular Metal Acetabular Revision System, Acetabular Liners and Constrained Liners | JDI | Substantially Equivalent | Zimmer Biomet | accessdata.fda.gov |
| July 18, 2025 | K251906 | Z1 Hip System | LZO | Substantially Equivalent | Zimmer, Inc. | accessdata.fda.gov |
| July 2, 2025 | K250848 | Identity Shoulder System | MBF | Substantially Equivalent | Zimmer, Inc. | accessdata.fda.gov |
| April 18, 2025 | K250834 | Zimmer Biomet Ceramic Heads (22.2mm diameter) | LZO | Substantially Equivalent | Zimmer Biomet | accessdata.fda.gov |
| March 6, 2025 | K243724 | Persona® Revision Knee System (Persona Revision SoluTion Femoral Components) | JWH | Substantially Equivalent | Zimmer, Inc. | accessdata.fda.gov |
| February 12, 2025 | K243907 | Affixus Tibial Nailing System - 4mm screws | HSB | Substantially Equivalent | Zimmer, Inc. | accessdata.fda.gov |
| December 11, 2024 | K241873 | OsseoFit Stemless Shoulder System | PKC | Substantially Equivalent | Zimmer, Inc. | accessdata.fda.gov |
| November 22, 2024 | K242543 | Persona the Personalized Knee System (Persona Ti-Nidium PPS Femurs) | MBH | Substantially Equivalent | Zimmer, Inc. | accessdata.fda.gov |
| October 29, 2024 | K243247 | Persona the Personalized Knee System | MBH | Substantially Equivalent | Zimmer, Inc. | accessdata.fda.gov |
| September 26, 2024 | K241651 | Affixus Tibial and Antegrade Femoral Nailing System | HSB | Substantially Equivalent | Zimmer, Inc. | accessdata.fda.gov |
| August 27, 2024 | K241241 | Z1 Cemented Hip System | LZO | Substantially Equivalent | Orchard Medical Development, LLC | accessdata.fda.gov |
| June 12, 2024 | K240876 | Identity Shoulder System | MBF | Substantially Equivalent | Zimmer, Inc. | accessdata.fda.gov |
| May 15, 2024 | K241043 | Augment Off-Axis Instrument System | PHX | Substantially Equivalent | Fix Surgical | accessdata.fda.gov |
| April 26, 2024 | K240299 | Persona the Personalized Knee System (Persona OsseoTi 3-Peg Patella) | MBH | Substantially Equivalent | Zimmer, Inc. | accessdata.fda.gov |
| March 22, 2024 | K233148 | Augment Off-Axis Instrument System | PHX | Substantially Equivalent | Fix Surgical | accessdata.fda.gov |
| February 8, 2024 | K233476 | Z1 Hip System | LZO | Substantially Equivalent | Orchard Medical Development | accessdata.fda.gov |
| December 12, 2023 | K232425 | Signature ONE System | QHE | Substantially Equivalent | Orthosoft Inc. (D/B/A) Zimmer Cas) | accessdata.fda.gov |
| March 8, 2023 | K230321 | Persona Personalized Knee System | JWH | Substantially Equivalent | Zimmer, Inc. | accessdata.fda.gov |
| November 17, 2022 | K221479 | Persona Personalized Knee System | JWH | Substantially Equivalent | Zimmer, Inc. | accessdata.fda.gov |
| September 15, 2022 | K213856 | Identity Shoulder System | MBF | Substantially Equivalent | Zimmer, Inc. | accessdata.fda.gov |
| April 28, 2022 | K212512 | G7® Vivacit-E® Freedom® Constrained Liner | PBI | Substantially Equivalent | Zimmer, Inc. | accessdata.fda.gov |
| December 10, 2021 | K210842 | VerSys Cemented Revision/Calcar | JDI | Substantially Equivalent | Zimmer, Inc. | accessdata.fda.gov |
| October 12, 2021 | K212560 | Signature ONE System | QHE | Substantially Equivalent | Orthosoft Inc (D/B/A Zimmer Cas) | accessdata.fda.gov |
| May 18, 2021 | K210829 | Persona Revision Knee System Femoral Metaphyseal Cones | JWH | Substantially Equivalent | Zimmer, Inc. | accessdata.fda.gov |
| July 16, 2020 | K191449 | ZCA All-Poly Acetabular Cups | JDI | Substantially Equivalent | Zimmer, Inc. | accessdata.fda.gov |
| July 9, 2020 | K200823 | Zimmer, Inc. Hip Joint Prostheses MR Labeling I | JDI | Substantially Equivalent | Zimmer, Inc. | accessdata.fda.gov |
| June 5, 2020 | K200615 | Signature ONE System | QHE | Substantially Equivalent | Orthosoft Inc (D/B/A Zimmer Cas) | accessdata.fda.gov |
| March 24, 2020 | K200209 | Persona Personalized Knee System | JWH | Substantially Equivalent | Zimmer, Inc. | accessdata.fda.gov |
| March 20, 2020 | K191735 | CPT Hip System | JDI | Substantially Equivalent | Zimmer, Inc. | accessdata.fda.gov |
| March 17, 2020 | K200151 | Persona Partial Knee Tibial Cut Guide 5 Deg Left Medial Right Lateral, Persona Partial Knee Tibial Cut Guide 5 Deg Right Medial Left Lateral, Persona Partial Knee 2MM Tibial Recutter Left Medial Right Lateral, Persona Partial Knee 2MM Tibial Recutter Right Medial Left Lateral, Persona Partial Knee Tibial Drill | HSX | Substantially Equivalent | Zimmer, Inc. | accessdata.fda.gov |
| February 28, 2020 | K192660 | Zimmer M/L Taper Hip Prosthesis | LZO | Substantially Equivalent | Zimmer, Inc. | accessdata.fda.gov |
| February 24, 2020 | K193180 | Alliance Augmented Glenoid | KWS | Substantially Equivalent | Zimmer, Inc. | accessdata.fda.gov |
| January 24, 2020 | K193223 | Persona Personalized Knee System | JWH | Substantially Equivalent | Zimmer, Inc. | accessdata.fda.gov |
| December 18, 2019 | K192189 | Avenir Complete Hip System, Size 0 Coxa Vara | LZO | Substantially Equivalent | Zimmer, Inc. | accessdata.fda.gov |
| December 6, 2019 | K190656 | Dual Mobility - Longevity and Vivacit-E Polyethylene Hip Bearings | LPH | Substantially Equivalent | Zimmer, Inc. | accessdata.fda.gov |
| December 5, 2019 | K190660 | G7 Acetabular System Longevity Highly Crosslinked Polyethylene, G7 Acetabular System Vivacit-E Vitamin E Highly Crosslinked Polyethylene | LPH | Substantially Equivalent | Zimmer, Inc. | accessdata.fda.gov |
| November 5, 2019 | K183457 | Zimmer Biomet 12/14 CoCr Femoral Head and Freedom Head | LPH | Substantially Equivalent | Zimmer, Inc. | accessdata.fda.gov |
| October 23, 2019 | K191814 | Alliance Glenoid | KWS | Substantially Equivalent | Zimmer, Inc. | accessdata.fda.gov |
| September 5, 2019 | K191625 | Persona Revision Knee System | JWH | Substantially Equivalent | Zimmer, Inc. | accessdata.fda.gov |
| August 30, 2019 | K192074 | Signature ONE System | QHE | Substantially Equivalent | Orthosoft Inc (D/B/A Zimmer Cas) | accessdata.fda.gov |
| July 5, 2019 | K191238 | Zimmer Guide Wire Devices | HSB | Substantially Equivalent | Zimmer, Inc. | accessdata.fda.gov |
| June 5, 2019 | K190595 | Signature ONE System | KWT | Substantially Equivalent | Orthosoft Inc (D/B/A Zimmer Cas) | accessdata.fda.gov |
| May 31, 2019 | K182678 | Zimmer M/L Taper Hip Prosthesis with Kinectiv Technology MR Labeling | LPH | Substantially Equivalent | Zimmer, Inc. | accessdata.fda.gov |
| May 10, 2019 | K183583 | Vanguard Complete Knee System | JWH | Substantially Equivalent | Zimmer, Inc. | accessdata.fda.gov |
| April 2, 2019 | K181171 | Zimmer Biomet Ceramic Heads | LZO | Substantially Equivalent | Zimmer, Inc. | accessdata.fda.gov |
| January 30, 2019 | K183136 | Zimmer Segmental System Proximal Femoral Component | LZO | Substantially Equivalent | Zimmer, Inc. | accessdata.fda.gov |
| January 28, 2019 | K181307 | Zimmer Nexel Total Elbow, Connrad/Morrey Total Elbow | JDC | Substantially Equivalent | Zimmer, Inc. | accessdata.fda.gov |
| December 26, 2018 | K181761 | Zimmer Biomet Select Ceramic Heads | LZO | Substantially Equivalent | Zimmer, Inc. | accessdata.fda.gov |
| December 14, 2018 | K181827 | Affixus Natural Nail System Humeral Nail | HSB | Substantially Equivalent | Zimmer GmbH | accessdata.fda.gov |
| December 7, 2018 | K182048 | Avenir Complete Hip System | LZO | Substantially Equivalent | Zimmer, Inc. | accessdata.fda.gov |
| October 25, 2018 | K181947 | Persona Revision Knee System | JWH | Substantially Equivalent | Zimmer, Inc. | accessdata.fda.gov |
| September 24, 2018 | K181611 | Comprehensive Reverse Shoulder System | PHX | Substantially Equivalent | Biomet Manufacturing Corp | accessdata.fda.gov |
| May 17, 2018 | K172524 | Zimmer Persona Personalized Knee System | MBH | Substantially Equivalent | Zimmer, Inc. | accessdata.fda.gov |
| March 29, 2018 | K173057 | Zimmer Knee Joint Replacement Prostheses MR Labeling | JWH | Substantially Equivalent | Zimmer, Inc. | accessdata.fda.gov |
| January 30, 2018 | K173417 | Zimmer Persona Personalized Knee System | MBH | Substantially Equivalent | Zimmer, Inc. | accessdata.fda.gov |
| December 28, 2017 | K171269 | X-PSI Knee System | JWH | Substantially Equivalent | Orthosoft Inc (D/B/A Zimmer Cas) | accessdata.fda.gov |
| November 30, 2017 | K172767 | Zimmer Trabecular Metal Reverse Shoulder System, Mini Glenoid | PHX | Substantially Equivalent | Zimmer, Inc. | accessdata.fda.gov |
| August 10, 2017 | K172114 | Zimmer Natural Nail System | HSB | Substantially Equivalent | Zimmer, Inc. | accessdata.fda.gov |
| November 3, 2016 | K161592 | Persona Partial Knee System | HSX | Substantially Equivalent | Biomet, Inc. | accessdata.fda.gov |
| October 26, 2016 | K161830 | Zimmer M/L Taper Hip Prosthesis | LZO | Substantially Equivalent | Zimmer, Inc. | accessdata.fda.gov |
| January 28, 2016 | K151716 | Cable-Ready Cable Grip System: Cable-Ready Bone Plate System | HRS | Substantially Equivalent | Zimmer, Inc. | accessdata.fda.gov |
| January 15, 2016 | K151848 | Cable-Ready® Cable Grip System: Cable-Ready Pin System, Cable-Ready Needle System | JDQ | Substantially Equivalent | Zimmer, Inc. | accessdata.fda.gov |
| December 30, 2015 | K151907 | Cable-Ready® Cable Grip System: Cable-Ready® GTR System, Cable-Ready® 1.8mm Cerclage Cables | KTT | Substantially Equivalent | Zimmer, Inc. | accessdata.fda.gov |
| December 21, 2015 | K152755 | FastFrame External Fixation System-Ankle Spanning | KTT | Substantially Equivalent | Zimmer, Inc. | accessdata.fda.gov |
| December 4, 2015 | K152484 | FastFrame External Fixation System - Distal Radius | KTT | Substantially Equivalent | Zimmer, Inc. | accessdata.fda.gov |
| November 25, 2015 | K152494 | Zimmer NexGen Complete Knee Solution Tibial and Femoral Augments | JWH | Substantially Equivalent | Zimmer, Inc. | accessdata.fda.gov |
| November 24, 2015 | K152841 | Zimmer Plates and Screws System (ZPS) Sterile 2.7mm Cortical Screws | HWC | Substantially Equivalent | Zimmer, Inc. | accessdata.fda.gov |
| November 2, 2015 | K151992 | FastFrame External Fixation System - Knee Spanning, FastFrame External Fixation System - Damage Control | KTT | Substantially Equivalent | Zimmer, Inc. | accessdata.fda.gov |
| August 13, 2015 | K151448 | Continuum and Trilogy Integrated Taper (IT) Acetabular Systems | LPH | Substantially Equivalent | Zimmer, Inc. | accessdata.fda.gov |
| July 1, 2015 | K150889 | Suture Wires and Wire Loops | JDQ | Substantially Equivalent | Zimmer, Inc. | accessdata.fda.gov |
| June 16, 2015 | K150730 | Zimmer PSI Shoulder System | KWT | Substantially Equivalent | Zimmer | accessdata.fda.gov |
| May 29, 2015 | K143321 | ITST Intertrochanteric/Subtrochanteric Fixation System | HSB | Substantially Equivalent | Zimmer, Inc. | accessdata.fda.gov |
| May 20, 2015 | K150090 | Zimmer Persona Personalized Knee System | MBH | Substantially Equivalent | Zimmer, Inc. | accessdata.fda.gov |
| May 1, 2015 | K150818 | Versa-Fx Femoral Fixation System, Versa-Fx II Femoral Fixation System, Free-Lock Femoral Fixation System | KTT | Substantially Equivalent | Zimmer, Inc. | accessdata.fda.gov |
| May 1, 2015 | K150626 | Rush Medullary Pins | HTY | Substantially Equivalent | Zimmer, Inc. | accessdata.fda.gov |
| April 23, 2015 | K150501 | Zimmer Nexel Total Elbow Ulnar Cement Diverter | JDC | Substantially Equivalent | Zimmer, Inc. | accessdata.fda.gov |
| March 31, 2015 | K143165 | Herbert/Whipple Bone Screw System, Herbert/Whipple Bone Screw System, Herbert Cannulated Bone Screw System, Herbert Mini Bone Screw | HWC | Substantially Equivalent | Zimmer, Inc. | accessdata.fda.gov |
| March 4, 2015 | K143331 | Zimmer Plates and Screws System (ZPS) - Non-sterile ZPS | HRS | Substantially Equivalent | Zimmer, Inc. | accessdata.fda.gov |
| February 23, 2015 | K150121 | Zimmer Periarticular Plating System | HRS | Substantially Equivalent | Zimmer, Inc. | accessdata.fda.gov |
| February 6, 2015 | K150028 | Zimmer Segmental System XT Components | KRO | Substantially Equivalent | Zimmer, Inc. | accessdata.fda.gov |
| February 6, 2015 | K143618 | Kirschner Wires, Steinmann Pins | HTY | Substantially Equivalent | Zimmer, Inc. | accessdata.fda.gov |
| December 22, 2014 | K142787 | Zimmer Persona Personalized Knee System | JWH | Substantially Equivalent | Zimmer, Inc. | accessdata.fda.gov |
| November 28, 2014 | K143066 | Zimmer Plates and Screws (ZPS) - Non Sterile Plate Line Extensions, Sterile/Non-Sterile ZPS / Screws and Washers | HRS | Substantially Equivalent | Zimmer, Inc. | accessdata.fda.gov |
| November 12, 2014 | K142836 | Zimmer Plates and Screws (ZPS), Forte Screws | HRS | Substantially Equivalent | Zimmer, Inc. | accessdata.fda.gov |
| October 22, 2014 | K142579 | Zimmer Periarticular Plating System | HRS | Substantially Equivalent | Zimmer, Inc. | accessdata.fda.gov |
| October 22, 2014 | K142281 | ZIMMER M/DN INTRAMEDULLARY FIXATION SYSTEM | HSB | Substantially Equivalent | Zimmer, Inc. | accessdata.fda.gov |
| October 3, 2014 | K142442 | MAGNA-FX AND MINI MAGNA-FX CANNULATED SCREW FIXATION SYSTEM | HWC | Substantially Equivalent | Zimmer, Inc. | accessdata.fda.gov |
| September 18, 2014 | K141697 | XTRAFIX EXTERNAL FIXATION SYSTEM, XTRAFIX SMALL EXTERNAL FIXATION SYSTEM | KTT | Substantially Equivalent | Zimmer, Inc. | accessdata.fda.gov |
| August 14, 2014 | K140508 | ZIMMER PLATES AND SCREWS SYSTEM(ZPS)- NON-STERILE PLATES AND SCREWS | HRS | Substantially Equivalent | Zimmer, Inc. | accessdata.fda.gov |
PMA approvals
Premarket approvals this establishment lists, with the supplements the FDA has decided since.
| Approved | PMA number | Device | Product code | Supplements | Latest decision | Source |
|---|---|---|---|---|---|---|
| December 10, 2007 | P060037 | NEXGEN LPS-FLEX MOBILE AND LPS-MOBILE BEARING KNEE SYSTEM | NJL | 98 | October 16, 2026 | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI. Newest 100 of 267.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| May 20, 2026 | 99045 | Class II | Ongoing | Off-Axis Comprehensive Shoulder System Small, Augment, Off-Axis, Reamer Guide, Model/Catalog Number: 110040240 | Five complaints have been received identifying issues where the plastic guides were catching during reaming, leading to breakage. | accessdata.fda.gov |
| May 11, 2026 | 99073 | Class II | Ongoing | Brand Name: Persona Revision Product Name: Persona Revision Trabecular Metal Femoral Distal Augment Model/Catalog Number: 42-5572-066-10 Software Version: N/A Product Description: Persona Revision Trabecular Metal Femora | Firm received a complaint with no clinical impact in which a posterior augment was found within the distal augment package. | accessdata.fda.gov |
| March 30, 2026 | 98665 | Class II | Ongoing | Brand Name: Disposable Mixing Bowls with Spatula Product Name: Mixing Bowl and Spatula Model/Catalog Number: 00-5049-011-00 Software Version: N/A Product Description: Mixing Bowl and Spatula Component: N/A | Ten complaints have been received identifying issues at the time of use related to the package seal, including incomplete seals, wrinkles in the seals or peeling seals. Compromised sterile barrier may lead to clinically insignificant extension of surgery or infection leading to surgical intervention. | accessdata.fda.gov |
| December 2, 2025 | 98069 | Class II | Ongoing | Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815509320 Software Version: N/A Product Description: Affixus 9 mm, Length 320 mm, Right, Trochanter | Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occurs include adverse local tissue reaction, pain or ache, non-union or malunion, or tissue damage necessitating surgical intervention. | accessdata.fda.gov |
| September 26, 2025 | 97765 | Class II | Ongoing | Zimmer Biomet Dual Mobility Vivacit-E Highly Crosslinked Polyethylene, 28 mm I.D., 44 mm O.D., Size F, Bearing, Model/Catalog Number: 110031012; semi constrained hip prosthesis | Zimmer Biomet is conducting a medical device recall for two (2) lots of the Dual Mobility Vivacit-E Bearing due to a commingle. The outer package is labeled as a Size F 44 mm, however, the implant inside the package is a Size G 46 mm, and vice versa. | accessdata.fda.gov |
| March 24, 2025 | 96493 | Class II | Ongoing | Zimmer Biomet Ceramic Head, 22.2 mm Diameter, 12/14 Taper, +0 Neck, Model Number 802602202; Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented or Non- Porous, Uncemented | The associated product labeling does not adequately provide compatibility information for use of the 22.2 mm Diameter Ceramic Femoral Heads with cobalt-chrome femoral stems or stainless-steel femoral stems. | accessdata.fda.gov |
| February 27, 2025 | 96400 | Class II | Ongoing | NexGen LPS Flex, Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis, Model Number 00-5962-042-10 | The "Use with plate 7, 8, 9, 10" compatibility statement on top of the label does not match with the compatibility statements "USE WITH PLATE 5, 6" in the translations section of the same label. | accessdata.fda.gov |
| February 12, 2025 | 96348 | Class II | Ongoing | Z1 Femoral Hip System, Product Number 611777612 | There is a potential design issue with the Z1 Offset Stem Inserter leading to fracturing of the distal tip. | accessdata.fda.gov |
| January 6, 2025 | 96090 | Class II | Ongoing | NexGen LCCK Legacy Articular Surface with Locking Screw - Striped Purple/C,D - Height 14 mm, Item Number 00-5994-022-14 | It was identified internally that two commingle events occurred where the metal support post within the polyethylene articular surface was assembled incorrectly for three units within the scope. | accessdata.fda.gov |
| September 17, 2024 | 95472 | Class II | Ongoing | Saphena Medical Venapax XL- Endoscopic Vessel Harvesting System for use in minimally invasive surgery allowing access for vessel harvesting and is primarily indicated for patients undergoing endoscopic surgery for arteri | A Gen 5 tail piece was assembled to a Gen 4 Finished Device, resulting in a 0.178" difference in the end of the endoscope slot to the end of the tail piece. This allows the scope to move further into the plastic sheath that runs the length of the device, resulting in an interference fit at the cone, may caus an extension in surgery | accessdata.fda.gov |
| July 2, 2024 | 94923 | Class II | Ongoing | CPT Hip Joint Metal/Polymer Semi-Constrained Cemented Prosthesis, used in Hip Arthroplasty; Item Numbers 00811400000 00811400010 00811400100 00811400110 00811400200 00811400210 00811400218 00811400230 00811400300 0081140 | Affected product has an increased risk of postoperative perisprosthetic femoral fracture (PFF). The IFU is being updated to reflect the risk of PFF. | accessdata.fda.gov |
| March 28, 2024 | 94327 | Class II | Ongoing | NexGen CR-Flex Femoral Component, Size E and Size E Minus (E-). Component of the NexGen CR-Flex Porous Femur System. | Out of specification violation of devices that results in a gap existing within the fixture that presses the fiber metal pad to the substrate, causing the pad to not fully bond to the substrate. | accessdata.fda.gov |
| March 20, 2024 | 94276 | Class II | Ongoing | ZPLP (Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plate, Right, 4 Holes, 80 MM, Sterile- Indicated for temporary internal fixation and stabilization of osteotomies and fractures Item Number: 47-2357 | Thread form issue for the locking holes in that the locking screws may not properly mate with the plate. The improperly mated screw may not be readily recognizable by the user since the screw may not correctly lock, may result in delay in surgery or loss of fixation resulting further intervention | accessdata.fda.gov |
| July 26, 2023 | 92889 | Class II | Ongoing | M/L Taper Hip Prosthesis Extended Offset, Reduced Neck Length, Size 4 (Item Number 00771100640) and Size 6 (Item Number 00771100440) | The outer package labeling and product etch are for a Size 6, however, the implant is a Size 4, and vice versa. | accessdata.fda.gov |
| June 27, 2023 | 92681 | Class II | Ongoing | Zimmer Periarticular Locking Plate (ZPLP) Distal Lateral Femoral Plate 6 holes 159 mm Length-Indicated for temporary internal fixation and stabilization of osteotomies and fractures, including comminuted fractures, supra | Thread form issue of the locking holes in that the locking screws would not properly mate with the plate. The improperly mated screw may not be readily recognizable by the user since the screw may not correctly lock. | accessdata.fda.gov |
| May 19, 2023 | 92531 | Class II | Terminated | NexGen Precoat Stemmed Tibial Plate Size 5 | Device outer packaging was incorrectly labeled. | accessdata.fda.gov |
| February 27, 2023 | 91842 | Class II | Ongoing | CoCr Femoral Head, XS, 38/-8, Taper 12/14-Intended to be used as a modular head component for articulation in total hip arthroplasty. Item Number: 01.01012.384 | Update the compatibility matrix as referred to in the Instructions for Use (IFU) for the CoCr Femoral Head XS- removes the compatibility with the Epsilon Durasul Constrained Acetabular Liners from the matrix due to the range of motion in flexion/extension being less than 100 degrees as recommended per an internationally recognized standard (ISO 21535:2009 | accessdata.fda.gov |
| December 7, 2022 | 91468 | Class II | Ongoing | Identity Shoulder System Resection Planer 35mm Resection Planer | Two planers were found to be unusable during sawbones shoulder training. | accessdata.fda.gov |
| December 6, 2022 | 91073 | Class II | Ongoing | NexGen Option Stemmed Tibial Component Size 3, Item Number 00-5986-037-01 | Zimmer Biomet is conducting a voluntary medical device recall related to the NexGen Stemmed Option Tibial Components due to the clinically and statistically significant higher overall revision rates when these tibial components are used with either the Legacy Posterior Stabilized (LPS) Flex or LPS Flex Gender Solutions Femoral (GSF) components as compared to | accessdata.fda.gov |
| August 25, 2022 | 90858 | Class II | Ongoing | G7 Acetabular System, Acetabular Shell, Item numbers Item Numbers: 010000663 (52 MM E), 010000667 (60 MM G). used in hip arthroplasty | The outer sterile package cavity has a corner wall thickness that is below the specification. The thin corner wall could potentially crack during transit. Potential risks include non-clinically or clinically significant extension of surgery, or infection leading to surgical intervention. | accessdata.fda.gov |
| November 20, 2020 | 86869 | Class II | Terminated | Spinal Rod Cutter, Item number 00392500200. The product is a nonsterile pin cutter - Product Usage: The intended use of this instrument is to be used for cutting orthopedic rods/pins during orthopedic surgeries. | Device has the potential for fracture during use. | accessdata.fda.gov |
| November 17, 2020 | 86762 | Class II | Terminated | Polaris 5.5 Spinal System and Polaris 5.5/Cypher Spinal System, Thoracolumbosacral pedicle screw system | Zimmer Biomet is conducting a medical device correction to update the Instructions for Use (IFU) and the Surgical Techniques for the Polaris Spinal System Translation Screw and Cypher MIS Screw System. Users should be aware that changes were made to the contraindications section indicating that the Translation Screws should not be used with a direct current | accessdata.fda.gov |
| September 24, 2020 | 86521 | Class II | Terminated | ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 22 mm, Neutral, O.D. Cup with Spacers, 43mm Item Number: 00-8065-540-22 Hip prosthesis component | Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Cannot rule out the potential for adverse tissue reactions. | accessdata.fda.gov |
| August 14, 2020 | 86404 | Class II | Terminated | Dual Mobility Vivacit-E Bearing, Model Number 110031009 | The outer package is labeled as a Size C 38 mm, however, the implant inside the package is a Size E 42 mm. | accessdata.fda.gov |
| May 5, 2020 | 85613 | Class II | Terminated | Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 4.5X30MM, Item Number 810M4530 - Product Usage: are non-cervical spinal fixation devices intended for posterior pedicle screw fixation, posterior hook fixation, | There are reports of inadequate locking of the extended tab screws. Complaints were reported where the closure top backed out of the screw post-operatively. | accessdata.fda.gov |
| December 23, 2019 | 84679 | Class II | Terminated | Jamshidi Bone Marrow Aspiration Needle Item Number: 00-1103-007-00 | Potential for the expiration date on the outer label that was applied by Zimmer Biomet to exceed the expiration date on the inner label | accessdata.fda.gov |
| December 12, 2019 | 84636 | Class II | Terminated | Coonrad/Morrey Total Elbow Humeral Assembly, Extra Small, 4-inch Length. Model No. 32-8105-027-04. UDI (01)00889024274006 (17)241031(10)64481139 The device is a Humeral component; elbow joint metal/polymer constrained ce | The lot contained two outer pins instead of one outer and one inner pin. | accessdata.fda.gov |
| October 10, 2019 | 83962 | Class II | Terminated | BF Humeral Stem, Various Sizes, Item Nos. 00430000606 00430000613 00430000706 00430000713 00430000813 00430000817 00430000820 00430000913 00430001013 00430001017 00430001020 00430001113 00430001213 00430001217 0043000122 | Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). | accessdata.fda.gov |
| April 18, 2019 | 82818 | Class II | Terminated | Biomet Oxford Partial Knee Phase 3 / Domed Lateral Femoral Drill Guide: Item Number: 32-420321 Phase 3 Femoral Drill Guide Small | Incorrect raw material used by the supplier in the manufacturing of the screw component, which could potentially lead to corrosion. | accessdata.fda.gov |
| November 14, 2018 | 82856 | Class II | Terminated | Lineum 4.35mm x 28mm Translation Screw, Model No. 14-524728 The Lineum OCT Spine System is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion for acute and chronic instabiliti | Etching on the tulip head incorrectly states "24MM" instead of the correct "28MM" marking. | accessdata.fda.gov |
| October 31, 2018 | 81604 | Class II | Terminated | NexGen Complete Knee Solution Femoral Augment Block Distal only, 15mm, Size E with Screw Item Number: 00599003523 NexGen Distal Femoral Augment Block is used when femoral components can neither be downsized nor can be di | Screw is missing from the package | accessdata.fda.gov |
| October 22, 2018 | 81394 | Class II | Terminated | Zimmer Pressure Sentinel Intramedullary Reaming System, Guide Wire, Bullet Tip, 2.4 mm Diameter Item Number: 00-2228-024-00 Product Usage: A single use surgical instrument used during orthopaedic surgery for implantation | Various Trauma Guide Wires- creases in the sealing area on the end opposite of the product's chevron opening compromising product sterility | accessdata.fda.gov |
| July 30, 2018 | 80879 | Class II | Terminated | Zimmer Natural Nail Tibial Nail - Yellow 8.3mm, Model Number 47249534008 Product Usage - The Zimmer Natural Nail System is intended for temporary fracture fixation and stabilization of the bone. Indications for the Tibia | The item is labeled as an 8.3mm, but it is actually a 12 mm. | accessdata.fda.gov |
| May 30, 2018 | 80188 | Class II | Terminated | Zimmer M/L Taper Hip Prosthesis Plasma Sprayed, Size 4 Extended Offset, 00-7711-004-40 | M/L Taper Hip Prosthesis and M/L Taper Hip Prosthesis with Kinectiv Technology manufactured prior to October 2015 are being recalled due to the potential for black residue to be observed within the polyethylene bag containing the implant. The black residue is a combination of the titanium plasma spray used to create the porous surface of the implant and poly | accessdata.fda.gov |
| March 29, 2018 | 79684 | Class II | Terminated | Zimmer Segmental System Proximal Femoral Component 38mm Offset, Model Number 00-5850-030-38 The Segmental System is used for solving complex salvage cases to address patients with severe bone loss associated with disease | There is a potential for debris in the hole on the superior lateral aspect of the device as a result of machining which may not have been adequately removed during the subsequent cleaning process. | accessdata.fda.gov |
| March 26, 2018 | 79681 | Class II | Terminated | M/DN Intramedullary Fixation Humeral Guide Wire - Smooth 2.4 mm Diameter 70 cm Length Single Use Only; Item Number: 00-2255-025-00 | Potential failure of sterile packaging seal. | accessdata.fda.gov |
| March 1, 2018 | 79406 | Class II | Terminated | Zimmer M/L Taper Hip Prosthesis, 7711 Series, Femoral Stem 12/14 Neck Taper Plasma Sprayed Press-Fit Cementless Size 7.5 Extended Offset Reduced Neck Length; Part Number: 00-7711-007-40 | Certain packages labeled as size 7.5 Extended Offset Reduced Neck length hip implant, actually contained a Size 4 Standard Reduced Neck length taper hip implant. | accessdata.fda.gov |
| February 19, 2018 | 81127 | Class I | Terminated | EBI Osteogen Implantable Bone Growth Stimulator The OsteoGen Implantable Bone Growth Stimulator is indicated in the treatment of long bone nonunions. | Lack of adequate validation and controls to ensure that product cleanliness parameters were consistently met. | accessdata.fda.gov |
| January 24, 2018 | 79400 | Class II | Terminated | Coonrad/Morrey Elbow Implant System humeral assembly 4IN XSML, Item Number: 32-8105-027-04 (UDI: (01)0088902427 4006(17)220731(10)63694912) | One lot of humeral stem implants do not include the humeral bushing components. | accessdata.fda.gov |
| January 3, 2018 | 79397 | Class II | Terminated | Trabecular Metal Primary Hip Prosthesis; Part Numbers: 1. 00-7864-013-00 (UDI: (01) 00889024139251 (17) 250731 (10) 63703649), and 2. 00-7864-013-20 (UDI: (01) 00889024139268 (17) 250731 (10) 63703681) | Two lots of hip implants are mislabeled. | accessdata.fda.gov |
| December 12, 2017 | 79394 | Class II | Terminated | PERSONA THE PERSONALIZED KNEE SYSTEM "PSN TIB STM 5 DEG SZ D R" indicated for patients with severe knee pain and disability due to: - Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis. | A complaint was received for Item 42-5320-067-02, lot 63236047. It was report that there was no set screw or taper plug included in the box. Complaint investigation confirmed that the entire lot of 63236047 was missing the set screw and taper plug. | accessdata.fda.gov |
| November 29, 2017 | 78706 | Class II | Terminated | BIPOLAR METAL SHELL 48 MM OD Use of the MultiPolar Bipolar Cup is indicated in: Total hip replacement | The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE bag on the implant after it is removed from the bag. | accessdata.fda.gov |
| October 3, 2017 | 79206 | Class II | Terminated | Flexible Shaft hip and anatomical shoulder instrument used for preparation of bone in Trauma, Hip and Shoulder surgeries.; Model Number: 75.80.04 | The Sirus Drill and Flexible Shaft instruments may not be adequately cleaned when utilizing the standard cleaning instructions potentially resulting in infection and subsequent complications. | accessdata.fda.gov |
| August 7, 2017 | 79991 | Class II | Terminated | Persona Stemmed Tibial Provisional Size H Left, Item Number 42532108301 For use during orthopaedic surgery for implantation of a prosthesis. | There is a potential for intermittent cracks in the raw material batch used to produce the affected products. The cleanliness of the affected products could be compromised if cracks penetrate the surface of the instrument as a result of the raw material issue. | accessdata.fda.gov |
| August 1, 2017 | 78762 | Class II | Terminated | Zimmer Segmental System, ZSS Distal Femur. Sizes as follows: a. Size B-LT (Item No. 00585001201); b. Size B-RT (Item No. 00585001202); c. Size C-LT (Item No. 00585001301); d. Size C-RT (Item No. 00585001302) Components o | The products being recalled exceeded the weight previously tested leading to a possibility of damage to the package and/or a compromised sterile barrier. | accessdata.fda.gov |
| June 5, 2017 | 78219 | Class II | Terminated | M/DN Intramedullary Fixation Humeral Guide Wire - Smooth 2.4 mm Diameter 70 cm Length Single Use Only, Item Number 00-2255-025-00 Product Usage: The Ball Tip and Tear Drop Guide Wires are used during the initial reaming | The design verification for the previous packaging configuration G928 does not cover the 70cm wires. A design verification has been completed to move the 70cm guide wires to a new packaging configuration. As a result, the products packaged in the previous packaging configuration are being removed. | accessdata.fda.gov |
| May 22, 2017 | 77417 | Class II | Terminated | Zimmer Trabecular Metal Reverse Shoulder System Instrumentation, Drill 2.5 mm Diameter, Item Number/EDI 47430904601, Sterile | Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw material with an anomaly. The anomaly may be on or below the surface and can increase the risk of instrument fracture. | accessdata.fda.gov |
| May 8, 2017 | 77223 | Class II | Terminated | Reusable instruments in the Knee, Hip, Trauma, and Extremities segments. | Durability characteristics of reusable instruments were not established | accessdata.fda.gov |
| April 28, 2017 | 77141 | Class II | Terminated | VERSA-FXII SC TUBE PLT 90DX16H, 95DX16H, 95DX18H, 95DX20H, 95DX22H | Zimmer Biomet is initiating a field action for sterile-packaged implants packaged in a single package configuration due to packaging design verification test failures. | accessdata.fda.gov |
| April 28, 2017 | 77140 | Class II | Terminated | NexGen Offset Stem Extension, sizes 14mm and 17mm For use in total arthroplasty. | Zimmer Biomet is conducting a lot-specific medical device field action for two lots of the NexGen Offset Stem Extension implants. Product complaints indicated that the size etched on the part and labeled on the product packaging were incorrect. | accessdata.fda.gov |
| February 28, 2017 | 76629 | Class II | Terminated | Por fullct fem st 20x200mm, Sterile, Rod, fixation, intramedullary and accessories- Specific Knee, Hip and Nail Implants | Zimmer Biomet Inc. initiated a field action on 02/28/2017 for sterile-packaged implants packaged in two different package configurations due to packaging design verification test failures. | accessdata.fda.gov |
| February 27, 2017 | 76820 | Class II | Terminated | MEDTECH ROSA Brain 3.0 The device is intended for the spatial positioning and orientation of instrument holders or tool guides to be used by neurosurgeons to guide standard neurosurgical instruments (biopsy needle, stimu | Unapproved change made by the supplier. | accessdata.fda.gov |
| October 11, 2016 | 77648 | Class II | Terminated | ROSA Brain, 3.0.0 The device is intended for the spatial positioning and orientation of instrument holders or tool guides to be used by neurosurgeons to guide standard neurosurgical instruments (biopsy needle, stimulatio | Complaint of the head holder connector locking up mechanically when tightened. | accessdata.fda.gov |
| September 28, 2016 | 75371 | Class II | Terminated | Zimmer Gender Solutions" Patellofemoral Joint Prosthesis Milling Handpiece | Complaints have been reported that the handpiece is inoperable. The investigation found that the complaints were related to the lack of preventative maintenance contrary to what is recommended in the instructions for use included with the handpiece. An inoperable device may lead to a delay in surgery | accessdata.fda.gov |
| August 16, 2016 | 74930 | Class II | Terminated | Coonrad/ Morrey Elbow Pin/ Bushing Replacement size Kit Extra Small. This product is sold sterile. The parts are placed into an inner cavity and are sealed using a nitrogen process. The inner cavity is then placed into a | Zimmer Biomet is conducting a voluntary medical device recall of a single lot of the Coonrad/ Morrey Elbow Pin/ Bushing Replacement size Kit Extra Small because the lot was packaged with a missing humeral bushing. The missing bushing could result in a surgical delay or additional surgery if a replacement is not available. | accessdata.fda.gov |
| July 29, 2016 | 77741 | Class II | Terminated | ROSA BRAIN 3.0.0 | Non-conforming product label. | accessdata.fda.gov |
| July 20, 2016 | 78367 | Class II | Terminated | ROSA Brain 3.0.0 Usage: The device is intended for the spatial positioning and orientation of instrument holders or tool guides to be used by neurosurgeons to guide standard neurosurgical instruments (biopsy needle, stim | Communication errors between ROSANNA BRAIN software, MARIO software and the Stubli CS8C controller. | accessdata.fda.gov |
| May 27, 2016 | 77742 | Class II | Terminated | ROSA Brain 3.0 Intended for the spatial positioning and orientation of instrument holders or tool guides to be used by neurosurgeons to guide standard neurosurgical instruments. The device is indicated for any neurosurgi | Insufficient amount of washers in the Telescopic Arm, allowing some movement of the device. | accessdata.fda.gov |
| May 11, 2016 | 74148 | Class II | Terminated | Persona Trabecular Metal Tibia; Persona Trabecular Metal Tibial Plate Instruments and Modular Brackets; Used to facilitate the implantation of joint replacement implants. | Zimmer Inc. is initiating a recall of specific Persona" Trabecular Metal" Tibial Plate Instruments and Modular Brackets, due to incidents of radiolucent lines and loosening in implants. | accessdata.fda.gov |
| April 8, 2016 | 77743 | Class II | Terminated | ROSA Surgical Device 2.5.8 | Potential for software to change the final tool orientation for the command position without command. | accessdata.fda.gov |
| February 11, 2016 | 73298 | Class II | Terminated | M/L Taper Hip Prosthesis (Item: 00-7711-012-20, Lot: 62937093 | Zimmer Biomet initiated a lot-specific voluntary recall on 02/11/2016, of the M/L Taper Hip Prosthesis. single manufacturing lot of Size 12.5, Extended Offset, M/L Taper hip stems was incorrectly etched. The device was etched as STD, rather than EXT. The product packaging is labeled correctly as Extended. Offset, and the device is an extended offset stem. | accessdata.fda.gov |
| January 20, 2016 | 77614 | Class II | Terminated | Herga foot switch, model 6289-WS, a component of the ROSA Robotized Stereotactic Assistant Surgical Device, Model 2.5.8. The firm name on the foot switch label is Herga Electric Limited, Bury, St. Edmunds, Suffolk IP32 6 | Complaints were received reporting the system would freeze/shut down while in Fulgurate mode. | accessdata.fda.gov |
| January 11, 2016 | 73142 | Class II | Terminated | LPS-FLEX GSF OPT prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer Various sizes Product Usage "" This device is indicated for patients with severe knee pain and disability due to: | LDPE bag containing the implant adheres to the highly polished implant surface. | accessdata.fda.gov |
| December 9, 2015 | 72944 | Class II | Terminated | Zimmer Universal Locking System 3.5mm Locking Reconstruction Plate Straight 11 Holes 144mm Length Zimmer Universal Locking System 3.5mm Locking Dual Compression Plate 8 Holes 105mm Length. Indicated for temporary interna | The product on the package label did not match what was inside the package. The label was for part number 00-4936-011-13 lot number 62968956 while the product inside the package was part number 00-4936-008-07 lot number 62968974. | accessdata.fda.gov |
| December 9, 2015 | 72938 | Class II | Terminated | Zimmer Periarticular Locking Plate System 3.5mm Locking Screw 58 mm Length; Zimmer Periarticular Locking Plate System 2.4mm Locking Screw 14 mm Length. Indicated for temporary internal fixation and stabilization of osteo | Product on the package label did not match what was inside the package. The label was for part number 00-2359-058-35 (Zimmer Periarticular Locking Plate System 3.5mm Locking Screw 58mm Length) lot number 62918019 while the product inside the package was part number 00-2359-014-24 (Zimmer Periarticular Locking Plate System 2.4mm Locking Screw 14mm Length) lot | accessdata.fda.gov |
| November 24, 2015 | 72714 | Class II | Terminated | Persona EM Proximal Tube, orthopedic manual surgical instrument for use with Persona Knee Prosthesis, item 42-5399-001-00, part of the Persona Tibial Resection System. | Complaints that the ratchet teeth of the tube are not latching onto the rod. | accessdata.fda.gov |
| November 17, 2015 | 72832 | Class II | Terminated | Zimmer, Virage OCT Spinal Fixation System, Item Number: 07.01738.001, a posterior system intended to achieve an implant and construct of the Occipital-Cervical-Thoracic spine (Occiput-T3). UDI Number 889024328952 | Zimmer Biomet is initiating a recall of the Virage Occipital Eyelet, as it was found through product testing that the staking of the set screw was out of specification and can interfere with the insertion of the occipital rod when the set screw is staked too low. | accessdata.fda.gov |
| November 10, 2015 | 72688 | Class II | Terminated | Zimmer UNIVERSAL Power System Loaner and Modular Electric/Battery Double Trigger Handpiece. Rx only Made in Switzerland | The firm identified a malfunction which made it possible for a handpiece to start by itself when the power source is connected. | accessdata.fda.gov |
| October 29, 2015 | 78443 | Class II | Terminated | Rosa Spine 1.0.2 Stereotaxic Instrument Computer-Assisted Surgical Device The device is intended for the spatial positioning and orientation of instrument holders or tool guides to be used by surgeons to guide standard n | A design change was initiated to update ROSA Spine 1.0.2 to version ROSA Spine 1.0.2.16 to resolve software bugs and improve usability and stability of the ROSA Spine device. | accessdata.fda.gov |
| August 27, 2015 | 72132 | Class II | Terminated | Zimmer Guide Wires for orthopedic procedures. | Product labeling of these sterile guide wires (external carton label and patient record label) states a 10-year expiration date. Package testing supports a 5-year expiration date for these same guide wires. | accessdata.fda.gov |
| August 11, 2015 | 72121 | Class II | Terminated | Zimmer Universal Locking System, Titanium 3.5mm. Zimmer Implant and Instrument Cases are reusable, non-implantable devices designed to facilitate organization, identification, storage, transportation, cleaning, and steri | It was found through review of open Complaints and stock investigations that a single lot of Zimmer Universal Locking System 3.5 mm Stainless Steel Base and Trays has incorrect silk screening as applied by the supplier. The T-plate catalog numbers noted in the tray are listed as the 00-4946-xxx-xx series (titanium plates); however, the correct numbers should | accessdata.fda.gov |
| June 17, 2015 | 71530 | Class II | Terminated | ZNN Antegrade Femoral Nail (ZNN AF). Orthopedic internal fixation device. | A single distributed ZNN Greater Trochanter Femoral Nail may have been dented. Potential for fatigue of implant prior to sufficient fracture healing, which may result in need for implant removal and revision of fracture fixation to assure proper healing and avoid fracture malunion or nonunion. | accessdata.fda.gov |
| May 18, 2015 | 71272 | Class I | Terminated | M/L Taper with Kinectiv Technology. prosthesis, hip, semi-constrained (metal uncemented acetabular component) Product Usage: Usage: Total hip replacement for the following: severe hip pain and disability due to rheumatoi | Zimmer is initiating a voluntary recall of 64 lots (752 implants total) of M/L Taper with Kinectiv femoral stems and modular necks due higher than allowed cytotoxicity levels found with the product. Reasonable probability of adverse biological response and subsequent revision | accessdata.fda.gov |
| April 30, 2015 | 71250 | Class II | Terminated | PRI Femoral Impactor Block for knee prosthesis surgery. Orthopedic Manual Surgical Instrument | Potential for uncured adhesive between the metal threaded insert and the impactor block to leak out of the assembled part following the autoclave sterilization process. The Master Bond epoxy serves as a secondary locking mechanism to fix the metal insert to the impactor head. Foreign material has been observed on the impactor block. This has the potential fo | accessdata.fda.gov |
| April 29, 2015 | 71243 | Class II | Terminated | Cortical Screw for M/DN Intramedullary Fixation. Metaphyseal/Diaphyseal Nail System, Orthopedic surgical device. | The entire scope of 4.5mm Cortical Screws listed as compatible with the M/DN system is not compatible with the M/DN system. This has the potential to lead to a situation in which the screw would bind upon entering the nail and have to be removed during the surgery or removal of the screw after fracture healing. | accessdata.fda.gov |
| April 2, 2015 | 71009 | Class II | Terminated | NexGen Augment; 5mm Distal Femoral Augment;Part number 00-5990-036-10. Intended to be used in total knee arthroplasty when there is insufficient bone in the distal femur. | The affected lot is being recalled because it was packaged without the locking screw. The locking screw packaged with the augment is used to fix the augment to the femoral component. This has the potential to delay surgery | accessdata.fda.gov |
| March 10, 2015 | 70676 | Class II | Terminated | Brand Name: Persona Anterior Referencing Sizer with Locking Boom The Persona Anterior Referencing Sizer is a sterilizable instrument intended for use in multiple total knee arthroplasty procedures. The Persona Surgical T | Zimmer, Inc is voluntarily recalling 22 lots of Persona Anterior Referencing Sizer with Locking Boom, part number 42-5099-088-10. Devices are being removed from distribution due to nonconforming to print specifications. | accessdata.fda.gov |
| February 5, 2015 | 70500 | Class II | Terminated | Zimmer Segmental System (ZSS) Cemented Stem / ZSS Cemented Stem, Smooth Stem Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented or Non-Porous, Uncemented. | PMMA coating does not meet specifications. Area of the stem may be missing PMMA coating. | accessdata.fda.gov |
| January 28, 2015 | 70523 | Class II | Terminated | Persona Trabecular Metal Tibial Plate / Persona TM Tibia-Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer For use in either posterior cruciate retaining or sacri | An increase in complaints of loosening and radiolucent lines. | accessdata.fda.gov |
| December 11, 2014 | 70240 | Class II | Terminated | Persona (TASP) Tibial Articular Surface Provisional Shim, all sizes and Lots Catalog Number: 42-5279-002-00 thru 42-5279-009-04. Product Usage: The Persona TASPs are sterilizable instruments Intended for multiple uses. T | Potential for delay in surgery and/or ball bearings to be left in the wound. Repeated cycles of sonic cleaning can break down the ball bearing retention feature (swage) on the shim. To prevent this, TASP shims must be manually cleaned and inspected per product insert, 87-6203-991-22. | accessdata.fda.gov |
| December 8, 2014 | 69904 | Class II | Terminated | Osteobond Bone Cement Bone cement monomer is kitted with bone cement powder to create a cement mantle for orthopedic implants. | Samples of product from Supplier lot 14D0809 and 14D0808 showed little adhesive transfer between the Tyvek lid and cavity when opened for internal bone cement cure and pairing tests. Visually these samples do not meet the requirements of ZWI 43.109 and corresponding visual aid 55-0000-310-01. | accessdata.fda.gov |
| December 4, 2014 | 69906 | Class II | Terminated | Persona Cemented Tibial Broach Inserter/Extractor. The Persona Cemented Tibial Broach Inserter/Extractor Handle is a Use sterilizable instrument intended for use In multiple TKA procedures. The Persona Surgical Technique | The affected lot was supplied by contract manufacturer and are potentially subject to disassociation of the magnet cover. Zimmer received one complaint indicating the magnet cover of a Persona Cemented Tibial Broach Inserter/Extractor Handle lot 62085420 was missing after broaching the tibia. Postoperative radiographs were inspected and the magnet cover was | accessdata.fda.gov |
| November 25, 2014 | 70105 | Class II | Terminated | Zimmer PERSONA Tibial Articular Surface Inserter; Item # 42-5299-001-00. Manual surgical instrument for knee arthroplasty (orthopedic). | Potential for fracture of the tip of the product. The fractured tip is approximately 4mm x 7mm x 3.5mm in size. Retained tip may result in: pain, soft tissue irritation, soft tissue damage, or increased wear due to contact with the fractured tip; Revision surgery to remove the fractured tip | accessdata.fda.gov |
| November 6, 2014 | 77626 | Class II | Terminated | ROSA Surgical Device 2.5.8, a computer-controlled electromechanical arm to guide standard neurosurgical instruments. | Potential failure of a force feedback sensor that may result in continued movement of an operating arm (rather than an immediate stop as intended). | accessdata.fda.gov |
| October 14, 2014 | 69366 | Class II | Terminated | Trabecular Metal Tibial Impactor. Product Usage: TM Tibial Impactor pads are used in conjunction with the TM Tibial Impactor to impact the tibial tray onto the tibia. | To provide clarifying instructions relating to the assembly/disassembly of the Trabecular Metal Tibial Impactor with/from TM tibial Impactor Pads due to complaints regarding Tibal Impactor pad fracture. | accessdata.fda.gov |
| October 9, 2014 | 69397 | Class II | Terminated | Persona Stemmed 5 Degree Cemented Tibia Product Usage: This device is indicated for patients with severe knee pain and disability due to: Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis. Collagen | Cleaning process validation failure. | accessdata.fda.gov |
| October 7, 2014 | 69354 | Class II | Terminated | The Persona Tibial Articular Surface Inserter is a sterilizable instrument intended for use in multiple total knee arthroplasty procedures. Per the Persona Surgical technique, the Persona Tibial Articular Inserter is use | Affected product did not undergo heat treatment hardening step leading to the potential for deformation of the tip. | accessdata.fda.gov |
| October 2, 2014 | 71531 | Class II | Terminated | Natural Knee II Revision Femoral Stem, 125mm, item 6215-12-185. packaged in configuration 803/791. Knee Prosthesis component. | Failed to meet established requirements for sterile barrier integrity due to a breach of the inner cavity. If the outer tray is compromised in addition to the inner tray a periprosthetic infection may occur. The risk associated with a periprosthetic infection is a revision or potential multi-stage revision to treat the infection. | accessdata.fda.gov |
| October 1, 2014 | 69301 | Class II | Terminated | Continuum Acetabular System Trabecular Metal Shell with Multi Holes, Porous 68mm, Prosthesis, Hip, Semi-Constrained, Metal/Polymer | The affected products are missing polar boss threads. | accessdata.fda.gov |
| September 9, 2014 | 69039 | Class II | Terminated | Persona The Personalized Knee System 2.5 mm Female Screw 48 mm Length Sterile Qty-2. Sterilized using irradiation, single use. | The Persona 48mm X 2.5mm Female Screw is being recalled due to potential use of the screw in cortical bone, and corresponding stripping of the 2.5mm Persona Hex Driver. | accessdata.fda.gov |
| September 5, 2014 | 78362 | Class II | Terminated | ROSA Surgical Device 2.5.8 ROSA Surgical Device is a computer-controlled electromechanical arm. It is intended to be used in the operating room for the spatial positioning and orientation of an instrument holder or tool | The software issue described was corrected in the modification to the MXTTOUT controller parameter settings. | accessdata.fda.gov |
| August 7, 2014 | 68878 | Class II | Terminated | PERSONA The Personalized Knee System Constrained Tibial Articular Surface Provisional BOTTOM with the following: L CD +0MM; L CD +6MM; L EF +0MM;L EF +6MM; L GH +0MM; L GH +6MM; L J +0MM; L J +6MM; R CD +0MM; R CD +6MM; | Reports of breakage of the Persona Knee Trial Articular Surface Provisionals (TASPs). The Persona primary knee surgical technique has been updated. This field action correction is to ensure that all distributors and users of this instrument are aware of the enhanced surgical techniques. | accessdata.fda.gov |
| July 30, 2014 | 68934 | Class II | Terminated | Zimmer Gender Solution Patello-Femoral Joint (PFJ) System Patello-Femoral Trochlea Component, Precoat, Size 4, Left. Knee prosthesis. | Internal review found that five (5) PFJ implant forgings were identified as have forged laps during receiving inspection process for raw material. These five forgings were not segregated and were subsequently issued to final manufacturing under Part 00-5926-014-01; lot 62455332. A forged lap is a defect that forms when metal folds over itself during forging. | accessdata.fda.gov |
| July 30, 2014 | 68801 | Class II | Terminated | Zimmer PERSONA Distal Valgus Alignment Guide, Nonsterile. orthopedic surgical instrument. The device sets the proper Varus/Valgus alignment of a patient's knee prior to the initial femoral resection cut being made. | Persona Distal Valgus Alignment guide collet locks are seizing in the 'unlocked' position. | accessdata.fda.gov |
| July 23, 2014 | 68656 | Class II | Terminated | Double Offset Rasp Handle, Left Hand Nonsterile | The firm received complaints for failure of the handle to remain assembled to the rasp during use due to various failure modes, including fracture of the leaf spring. | accessdata.fda.gov |
| July 22, 2014 | 68819 | Class II | Terminated | Magna-Fx Cannulated Screw Fixation System Bone Screw Fully Threaded Sterile zimmer | Zimmer is recalling various trauma screws that failed a leak test due to damage of the inner cavity only. | accessdata.fda.gov |
| July 22, 2014 | 68818 | Class II | Terminated | Knee Instrument Fixation Screws: 48MM HEADED SCREW 48MM HEADLESS SCREW MIS HEADED SCREW, 48MM MIS HEADLESS SCREW, 48MM | Zimmer is recalling sterile-packaged implants and instruments packaged in six different package configurations due to packaging design verification test failures. Specifically, multiple test samples from each of the six configurations failed simulated distribution and shipping testing when the devices either breached inner or outer package trays or seal inte | accessdata.fda.gov |
| July 17, 2014 | 68862 | Class II | Terminated | Tapered-Screw Vent Implant, HA, 4.7mmD x 8mmL x 4.5mm, Part No. TSVWH8 Dental implant component. | Zimmer Dental is recalling the Tapered Screw-Vent Implant because the inner vial state "03.7 x 8mm" instead of "04.7 x 8 mm." | accessdata.fda.gov |
| July 10, 2014 | 68655 | Class II | Terminated | Natural-Knee System Patella Bushings. Orthopedic surgical instrument. Part Number 6290-00-690. Per the Natural-Knee II Primary System Surgical Technique, the patellar bushing is placed on the cut surface of the patella a | Zimmer received a trend of complaints indicating corrosion of product. | accessdata.fda.gov |
| July 1, 2014 | 68654 | Class II | Terminated | Moore Hip Prosthesis Long Fenestrated Stem 38 mm (1-1/2 Inch) Head Diameter 203 mm Length. Product Usage: The Moore Hip Prosthesis is a femoral him stem that can be used where there is roentgenogrpahic evidence of a sati | Zimmer is initiating a voluntary recall of 20 production lots of Moore Hip Prosthesis Long Fenestrated Stems due to packaging design verification test failures. Specifically, 9 of 16 test samples failed simulated distribution and shipping testing when the Moore hip stem breached either the inner or outer package tray. Zimmer has not received any complaints o | accessdata.fda.gov |
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Updated October 16, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.