Data / Medical devices / United States / Biomet, Inc.
Biomet, Inc.: FDA-registered device maker in Warsaw, IN, United States, 613 510(k) clearances and 1 PMA approval
Biomet, Inc. is registered with the FDA (registration 1825034) in Warsaw, IN, United States. It lists 204 device types. The FDA files 613 510(k) clearances and 1 PMA approval under its listings, the newest dated September 23, 2026. 254 recall events name it as the recalling firm (1 Class I). Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 1825034
- Address
- 56 E Bell Dr Po Box 587, Warsaw, IN, United States, 46581
- Owner or operator
- Zimmer Inc (1825034)
- Roles
- Contract manufacturer, Manufacturer, Manufacturer for export, Remanufacturer, Repackager or relabeler, Specification developer
- First device listed
- December 28, 1977
- Registered through
- 2027
- Brand names listed
- & BONE SCREWS, (BEARINGS / TRAYS), - GLENOID GUIDE SYSTEM, /LORENZ 2 FT PLATES, 1.5MM SMALL LOCKING PLATE, 1.5MM NON-LOCKING AND LOCKING SCREWS, 1.5MM, 2MM SYSTEM, 100KGY E-POLY ACETABULAR LINERS- ADDITIONAL PROFILES: +3, 100KGY E-POLY ACETABULAR LINERS-ADDITIONAL PROFILES 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 613.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| September 23, 2026 | K261453 | G7® Acetabular System | LPH | Substantially Equivalent | Zimmer Biomet | accessdata.fda.gov |
| August 24, 2026 | K253515 | Zimmer Biomet OSS Orthopedic Salvage System OsseoTi® Sleeves and Augments | JDI | Substantially Equivalent | Biomet Orthopedics, Inc. | accessdata.fda.gov |
| July 1, 2026 | K253434 | OSSTM Orthopedic Salvage System | JDI | Substantially Equivalent | Biomet, Inc. | accessdata.fda.gov |
| May 19, 2026 | K251270 | Taperloc® Complete Hip Stem | LPH | Substantially Equivalent | Biomet, Inc. | accessdata.fda.gov |
| April 15, 2026 | K252404 | Comprehensive Reverse Shoulder - HA Glenosphere Baseplates | PHX | Substantially Equivalent | Biomet Orthopedics | accessdata.fda.gov |
| August 15, 2025 | K251834 | Persona Partial Knee | HSX | Substantially Equivalent | Zimmer Biomet | accessdata.fda.gov |
| July 25, 2025 | K251620 | A.L.P.S. Proximal Humerus Plating System | HRS | Substantially Equivalent | Zimmer Biomet | accessdata.fda.gov |
| February 19, 2025 | K243761 | A.L.P.S. Small Fragment Plating System | HRS | Substantially Equivalent | Biomet Orthopedics | accessdata.fda.gov |
| May 22, 2024 | K241014 | Biomet Kirschner Wires (K-Wires) | HTY | Substantially Equivalent | Biomet, Inc. | accessdata.fda.gov |
| July 25, 2023 | K230540 | Patient Specific Planning Solution 3D Bone Models | LLZ | Substantially Equivalent | Biomet Manufacturing Corp | accessdata.fda.gov |
| July 12, 2023 | K223631 | Comprehensive Segmental Revision System(SRS) | KWT | Substantially Equivalent | Biomet Orthopedics | accessdata.fda.gov |
| December 28, 2022 | K222760 | StageOne Select Hip Cement Spacer Molds | MBB | Substantially Equivalent | Biomet, Inc. | accessdata.fda.gov |
| September 15, 2022 | K221968 | StageOne Shoulder Cement Spacer Molds | MBB | Substantially Equivalent | Biomet, Inc. | accessdata.fda.gov |
| September 2, 2022 | K213287 | StageOne Knee Cement Spacer Molds | MBB | Substantially Equivalent | Biomet, Inc. | accessdata.fda.gov |
| December 10, 2021 | K212435 | Comprehensive Humeral Fracture Positioning Sleeves | KWS | Substantially Equivalent | Biomet, Inc. | accessdata.fda.gov |
| November 4, 2021 | K211729 | Comprehensive® Convertible Glenoid - Vivacit-E Liner | PHX | Substantially Equivalent | Biomet Manufacturing Corp | accessdata.fda.gov |
| February 19, 2021 | K210192 | A.L.P.S. Clavicle Plating System | HRS | Substantially Equivalent | Biomet, Inc. | accessdata.fda.gov |
| February 19, 2021 | K202232 | Comprehensive Vault Reconstruction System | PHX | Substantially Equivalent | Biomet Manufacturing Corp | accessdata.fda.gov |
| December 8, 2020 | K200196 | Taperloc® Complete Hip Stems | LZO | Substantially Equivalent | Biomet Orthopedics | accessdata.fda.gov |
| October 28, 2020 | K193038 | Comprehensive Shoulder System | MBF | Substantially Equivalent | Biomet Manufacturing Corp | accessdata.fda.gov |
| September 25, 2020 | K193546 | Distal Centralizers | JDG | Substantially Equivalent | Biomet, Inc. | accessdata.fda.gov |
| April 15, 2020 | K193373 | Comprehensive® Reverse Shoulder | PHX | Substantially Equivalent | Biomet, Inc. | accessdata.fda.gov |
| March 5, 2020 | K193402 | ALLthread PEEK Suture Anchor | MBI | Substantially Equivalent | Biomet, Inc. | accessdata.fda.gov |
| February 24, 2020 | K193451 | Titanium Interference Screws | HWC | Substantially Equivalent | Biomet, Inc. | accessdata.fda.gov |
| February 20, 2020 | K193533 | WIN Flexible Nail System | JDS | Substantially Equivalent | Biomet, Inc. | accessdata.fda.gov |
| January 16, 2020 | K192942 | ALLthread Titanium Suture Anchor | MBI | Substantially Equivalent | Biomet, Inc. | accessdata.fda.gov |
| January 2, 2020 | K193092 | TunneLoc Tibial Fixation Device | MBI | Substantially Equivalent | Biomet, Inc. | accessdata.fda.gov |
| September 13, 2019 | K191459 | JuggerStitch Meniscal Repair Device | MBI | Substantially Equivalent | Biomet, Inc. | accessdata.fda.gov |
| June 10, 2019 | K190814 | AccuFill Bone Substitute Material | MQV | Substantially Equivalent | Zimmer Knee Creations | accessdata.fda.gov |
| April 22, 2019 | K182516 | Comprehensive Nano Stemless Shoulder | PKC | Substantially Equivalent | Biomet Manufacturing Corp | accessdata.fda.gov |
| February 7, 2019 | K190035 | Biomet Headless Compression and Twist-Off Screws | HWC | Substantially Equivalent | Biomet, Inc. | accessdata.fda.gov |
| January 22, 2019 | K183553 | Compress and Mini Compress Anti-Rotation Spindles | MBF | Substantially Equivalent | Biomet, Inc. | accessdata.fda.gov |
| April 6, 2018 | K173767 | A. L. P. S. Clavicle Plating System | HRS | Substantially Equivalent | Biomet, Inc. | accessdata.fda.gov |
| February 8, 2018 | K173411 | Comprehensive Segmental Revision System (SRS) | PHX | Substantially Equivalent | Biomet Manufacturing Corp | accessdata.fda.gov |
| February 7, 2018 | K173826 | THP Hip Fracture Plating System | JDO | Substantially Equivalent | Biomet, Inc. | accessdata.fda.gov |
| January 5, 2018 | K173278 | ToggleLoc System | MBI | Substantially Equivalent | Biomet, Inc. | accessdata.fda.gov |
| January 3, 2018 | K172502 | Comprehensive Augmented Glenoid Components, Comprehensive Standard Baseplate, Comprehensive Mini Baseplate | PHX | Substantially Equivalent | Biomet Manufacturing Corp | accessdata.fda.gov |
| July 28, 2017 | K171054 | Biomet Knee Joint Replacement Prostheses | JWH | Substantially Equivalent | Biomet, Inc. | accessdata.fda.gov |
| February 17, 2017 | K163651 | ExpressBraid Graft Manipulation | GAT | Substantially Equivalent | Biomet Manufacturing Corp | accessdata.fda.gov |
| January 25, 2017 | K161273 | StageOne Disposable Cement Spacer Molds for Temporary Knee Prosthesis | MBB | Substantially Equivalent | Biomet, Inc. | accessdata.fda.gov |
| November 3, 2016 | K161592 | Persona Partial Knee System | HSX | Substantially Equivalent | Biomet, Inc. | accessdata.fda.gov |
| September 8, 2016 | K161166 | StageOne Select Cement Spacer Molds for Temporary Hip Replacement | MBB | Substantially Equivalent | Biomet, Inc. | accessdata.fda.gov |
| June 16, 2016 | K160071 | StageOne Disposable Cement Spacer Molds for Temporary Hemi-Shoulder Prosthesis | MBB | Substantially Equivalent | Biomet, Inc. | accessdata.fda.gov |
| May 26, 2016 | K161190 | G7 Dual Mobility System, Active Articulation System | LPH | Substantially Equivalent | Biomet, Inc. | accessdata.fda.gov |
| May 16, 2016 | K152754 | COMPREHENSIVE VAULT RECONSTRUCTION SYSTEM (VRS) | PHX | Substantially Equivalent | Biomet Manufacturing Corp | accessdata.fda.gov |
| May 10, 2016 | K153657 | Vanguard XP Knee System | MBH | Substantially Equivalent | Biomet, Inc. | accessdata.fda.gov |
| March 9, 2016 | K160058 | Biomet Variable Pitch Compression Screw System | HWC | Substantially Equivalent | Biomet, Inc. | accessdata.fda.gov |
| February 8, 2016 | K152868 | ExpressBraid Graft Manipulation | GAT | Substantially Equivalent | Biomet Manufacturing Corp | accessdata.fda.gov |
| February 3, 2016 | K153398 | Comprehensive SRS/Nexel Elbow | JDC | Substantially Equivalent | Biomet Manufacturing Corp | accessdata.fda.gov |
| October 14, 2015 | K152621 | OSS/Arcos IM Total Femur Rod | JDI | Substantially Equivalent | Biomet, Inc. | accessdata.fda.gov |
| October 6, 2015 | K151603 | Arcos One-piece Femoral Revision System | LPH | Substantially Equivalent | Biomet, Inc. | accessdata.fda.gov |
| October 2, 2015 | K151615 | TiTHON Staple with OsseoTi Technology | JDR | Substantially Equivalent | Biomet Manufacturing Corp | accessdata.fda.gov |
| September 4, 2015 | K150768 | JuggerKnot Soft Anchors | MBI | Substantially Equivalent | Biomet Manufacturing Corp | accessdata.fda.gov |
| June 25, 2015 | K142814 | Biomet Orthopaedic Salvage System (OSSTM) - Proximal Femoral & Hybrid Tibial | JDI | Substantially Equivalent | Biomet Manufacturing, LLC | accessdata.fda.gov |
| June 10, 2015 | K150867 | Affixus Tibial Nailing System | HSB | Substantially Equivalent | Biomet, Inc. | accessdata.fda.gov |
| May 15, 2015 | K150424 | JuggerStitch Meniscal Repair Device | MBI | Substantially Equivalent | Biomet Manufacturing Corp | accessdata.fda.gov |
| May 1, 2015 | K150522 | G7 Dual Mobility System | LPH | Substantially Equivalent | Biomet, Inc. | accessdata.fda.gov |
| March 30, 2015 | K143697 | Biomet Proximal Humerus Plating System | HRS | Substantially Equivalent | Biomet Manufacturing | accessdata.fda.gov |
| March 25, 2015 | K150503 | Echo Bi-Metric Microplasty Line Extension | LPH | Substantially Equivalent | Biomet, Inc. | accessdata.fda.gov |
| February 12, 2015 | K143192 | Vanguard 360 Revision Knee System | JWH | Substantially Equivalent | Biomet, Inc. | accessdata.fda.gov |
| February 10, 2015 | K142882 | G7 Freedom and Offset Liners, Freedom Head, Size 32 | LPH | Substantially Equivalent | Biomet, Inc. | accessdata.fda.gov |
| January 30, 2015 | K143543 | Prelude PF Patellae | KRR | Substantially Equivalent | Biomet, Inc. | accessdata.fda.gov |
| January 20, 2015 | K143037 | SnapShot Fixation System | JDR | Substantially Equivalent | Biomet Manufacturing Corp | accessdata.fda.gov |
| December 30, 2014 | K143188 | 3.Omm Biomet Cannulated Screw System | HWC | Substantially Equivalent | Biomet Manufacturing Corp | accessdata.fda.gov |
| December 29, 2014 | K142746 | G7 Finned Acetabular Shell | LPH | Substantially Equivalent | Biomet Manufactuting Corp. | accessdata.fda.gov |
| December 23, 2014 | K142933 | Biomet Tibial trays | JWH | Substantially Equivalent | Biomet, Inc. | accessdata.fda.gov |
| December 18, 2014 | K143009 | Echo Bi-Metric Microplasty Hip System | LPH | Substantially Equivalent | Biomet, Inc. | accessdata.fda.gov |
| December 11, 2014 | K140669 | G7 OSSEOTI ACETUBLAR SHELLS | LPH | Substantially Equivalent | Biomet, Inc. | accessdata.fda.gov |
| November 19, 2014 | K141263 | TOGGLELOC AND JUGGERLOC IMPLANTS/INSTRUMENTS/KITS | JDR | Substantially Equivalent | Biomet Manufacturing Corp | accessdata.fda.gov |
| November 13, 2014 | K142658 | Biomet Headless Compression and Twist-off Screws | HWC | Substantially Equivalent | Biomet Manufacturing Corp | accessdata.fda.gov |
| October 27, 2014 | K141407 | VANGUARD XP FEMORAL COMPONENT(GEN II)/VANGUARD XP FEMORAL TRIAL | MBH | Substantially Equivalent | Biomet, Inc. | accessdata.fda.gov |
| October 27, 2014 | K141331 | BIOMET ORTHOPAEDIC SALVAGE SYSTEM (OSS) | JDI | Substantially Equivalent | Biomet, Inc. | accessdata.fda.gov |
| October 2, 2014 | K140908 | JUGGERKNOT MINI SOFT ANCHOR | DZL | Substantially Equivalent | Biomet Sports Medicine | accessdata.fda.gov |
| September 15, 2014 | K142295 | Sirius Femoral Stem, Size 30A | JDI | Substantially Equivalent | Biomet, Inc. | accessdata.fda.gov |
| September 10, 2014 | K140390 | TITANIUM VERSA-DIAL HUMERAL HEAD PROSTHESIS | MBF | Substantially Equivalent | Biomet Manufacturing Corp | accessdata.fda.gov |
| August 27, 2014 | K141762 | PERFUSE PERCUTANEOUS DECOMPRESSION SYSTEM | FMF | Substantially Equivalent | Biomet, Inc. | accessdata.fda.gov |
| July 30, 2014 | K140883 | VANGUARD 360 OSSEOTI TIBIAL SLEEVE AUGMENT | MBH | Substantially Equivalent | Biomet, Inc. | accessdata.fda.gov |
| July 18, 2014 | K141219 | JUGGERLOC BONE TO BONE IMPLANTS/ BONE INSTRUMENTS/ BONE IMPLANT AND INSTRUMENT KITS | HTN | Substantially Equivalent | Biomet Manufacturing Corp | accessdata.fda.gov |
| July 3, 2014 | K140902 | E1 SERIES A PATELLAE, STANDARD 3-PEG, E1 SERIES A PATELLAE, THIN 3-PEG, E1 SERIES PATELLAE, ASYMMETRICAL, 3-PEG | JWH | Substantially Equivalent | Biomet, Inc. | accessdata.fda.gov |
| July 3, 2014 | K140652 | POROUS COATED COMPREHENSIVE FRACTURE STEMS | PHX | Substantially Equivalent | Biomet Manufacturing Corp | accessdata.fda.gov |
| June 3, 2014 | K140891 | BIOMET CANNULATED SCREW SYSTEM | HWC | Substantially Equivalent | Biomet, Inc. | accessdata.fda.gov |
| May 28, 2014 | K140509 | BIOMET SIDE ACCESS DISTAL FEMORAL EXPANDABLE | KRO | Substantially Equivalent | Biomet Manufacturing, LLC | accessdata.fda.gov |
| May 13, 2014 | K140622 | DVR DORSAL PLATE, DVR LATERAL PLATE, DVR ULNA PLATE | HRS | Substantially Equivalent | Biomet, Inc. | accessdata.fda.gov |
| April 18, 2014 | K140625 | ORTHOSORB LS | OVZ | Substantially Equivalent | Biomet, Inc. | accessdata.fda.gov |
| April 4, 2014 | K140018 | TSP HIP FRACTURE PLATING SYSTEM | JDO | Substantially Equivalent | Biomet, Inc. | accessdata.fda.gov |
| April 1, 2014 | K133939 | MODIFIED DISTAL RADIUS PLATING SYSTEM | HRS | Substantially Equivalent | Biomet | accessdata.fda.gov |
| March 28, 2014 | K133940 | OXFORD FIXED LATERAL BEARING PARTIAL KNEE REPLACEMENT (BEARINGS / TRAYS) | HRY | Substantially Equivalent | Biomet UK, Ltd. | accessdata.fda.gov |
| January 22, 2014 | K131135 | BIOMET STAGE ONE DISPOSABLE CEMENT SPACER MOLDS FOR TEMPORARY HEMI-SHOULDER PROSTHESIS | MBB | Substantially Equivalent | Biomet Manufacturing Corp | accessdata.fda.gov |
| December 11, 2013 | K132873 | VANGUARD XP KNEE SYSTEM | MBH | Substantially Equivalent | Biomet, Inc. | accessdata.fda.gov |
| November 19, 2013 | K132898 | A.L.P.S. CALCANEAL PLATING SYSTEM | HRS | Substantially Equivalent | Biomet Manufacturing Corp | accessdata.fda.gov |
| October 29, 2013 | K131867 | 2.5MM INLINE FUSION PLATE | HRS | Substantially Equivalent | Biomet, Inc. | accessdata.fda.gov |
| October 24, 2013 | K131393 | MAK OSS FEMORAL KNEE COMPONENTS | KRO | Substantially Equivalent | Biomet Orthopedics Corp. | accessdata.fda.gov |
| October 18, 2013 | K122437 | NO-PROFILE SCREWS NO-PROFILE WASHER NO-PROFILE SCREWS WASHERLOC WASHERS | MBI | Substantially Equivalent | Biomet Sports Medicine | accessdata.fda.gov |
| October 9, 2013 | K132704 | DISTAL RADIUS VOLAR RIM PLATE STANDARD, DISTAL RADIUS VOLAR RIM PLATE NARROW | LXT | Substantially Equivalent | Biomet | accessdata.fda.gov |
| October 9, 2013 | K130390 | COMPREHENSIVE CONVERTIBLE GLENOID | PHX | Substantially Equivalent | Biomet Manufacturing, Inc. | accessdata.fda.gov |
| October 8, 2013 | K131353 | COMPREHENSIVE REVERSE SHOULDER - TITANIUM GLENOSPHERE | PHX | Substantially Equivalent | Biomet Manufacturing Corp | accessdata.fda.gov |
| September 6, 2013 | K132239 | COMPREHENSIVE REVERSE SHOULDER SCREWS | PHX | Substantially Equivalent | Biomet Manufacturing Corp | accessdata.fda.gov |
| September 3, 2013 | K123907 | PRELUDE PF FEMORAL COMPONENTS (MIM COCRMO), PRELUDE PF FEMORAL COMPONENTS (CAST COCRMO), PRELUDE PF PATELLA COMPONENTS, | KRR | Substantially Equivalent | Biomet Manufacturing Corp | accessdata.fda.gov |
| August 30, 2013 | K130610 | SIRIUS FEMORAL STEM | JDI | Substantially Equivalent | Biomet, Inc. | accessdata.fda.gov |
| August 6, 2013 | K130126 | SIGNATURE PERSONALIZED PATIENT CARE SYSTEM - GLENOID GUIDE SYSTEM | MBF | Substantially Equivalent | Biomet, 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 |
|---|---|---|---|---|---|---|
| April 21, 2004 | P010014 | OXFORD(TM) MENISCAL UNICOMPARTMENTAL KNEE SYSTEM | NRA | 107 | October 6, 2026 | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI. Newest 100 of 254.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| July 1, 2026 | 99346 | Class II | Ongoing | Intramedullary Bone Saw Blade Assembly Model/Catalog Number: 475620 Product Description: Intramedullary Bone Saw Blade Assembly 12mm | Zimmer Biomet is conducting a medical device recall removal for various sizes of the Intramedullary Bone Saw Blade Assembly due to potential sterile barrier packaging damage caused by an exposed saw blade. | accessdata.fda.gov |
| September 23, 2025 | 97670 | Class II | Ongoing | BIOMET ZipTight, Acute AC Joint Implant, Single Ziploop, Model/Catalog Number: 904834; Fixation System for AC Joint Repair | There is a potential for a missing slotted button assembly in one lot of ZipTight, Acute AC Joint Implant, Single Ziploop | accessdata.fda.gov |
| September 9, 2025 | 97570 | Class II | Ongoing | Juggerknot Mini Soft Anchors, Model/Catalog Number: 912080 | The outer carton box label is for the JuggerKnot 1.0mm Mini products. However, the products within the carton are JuggerKnot 1.4mm Short devices. | accessdata.fda.gov |
| October 21, 2024 | 95597 | Class II | Ongoing | JuggerLoc/ToggleLoc 2.9mm Drill Guide, Model number 110027357 | Firm received complaints reporting that guides were warped when pulled out of packaging. This issue may result in extension of surgery to find another product, or may lead to adverse local tissue reaction leading to surgical intervention. | accessdata.fda.gov |
| May 17, 2024 | 94742 | Class II | Ongoing | RingLoc Bi-Polar Hip System Acetabular Cup, 41 mm Outer Diameter - Used in hip hemi-arthroplasty Item Number: 11-165206 | 41 mm acetabular outer heads were potentially assembled with a 42 mm locking ring, may lead to joint instability leading requiring surgical intervention | accessdata.fda.gov |
| March 13, 2024 | 94310 | Class II | Ongoing | Vanguard Knee System AS Tibial Bearing / DCM ArCom, 12 MM X 75 MM; Model Number 189082. The product is placed into a foil pouch with protective packaging in the form of a polyurethane bag, and sealed closed (inner barrie | Possible damage to the Vanguard Knee System AS Tibial Bearing caused during the manufacturing process. | accessdata.fda.gov |
| November 2, 2023 | 93486 | Class II | Ongoing | Biolox Ceramic Option Head Zimmer 12/14 40mm -3, Item Number 00-8777-040-01 | One product complaint was received reporting that there was an incorrect adapter in the packaging. An adapter with neck length M/+0 was inside the product packaging, which should have contained an adapter with neck length S/-3.0. The difference in neck length may be recognized by the size (S or M) indicator on the device. | accessdata.fda.gov |
| October 9, 2023 | 93323 | Class II | Ongoing | Compress Device Segmental Anchor Plug, 10 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement. Item Number: 178400 | Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the drill or pins from passing through, may result in extension of surgery | accessdata.fda.gov |
| February 6, 2023 | 91866 | Class II | Ongoing | G7 Acetabular System, Dual Mobility Acetabular Liner, 40 mm, Size D, Model Number 110024462 | The outer package labeling and product etch are a 40 mm Size D liner, however, the implant is a 38 mm Size C liner. | accessdata.fda.gov |
| December 29, 2022 | 91489 | Class II | Ongoing | (1) Vanguard Knee System PS Open Box Femoral; Right; 60 mm. Intended for knee joint replacement prostheses. Item Number: 183104 (2) Vanguard Knee System PS Open Box Femoral; Right; 62.5 mm Item Number: 183106 (3) Vanguar | Components Incorrectly labeled as either smaller or larger and incorrect side (right/left). | accessdata.fda.gov |
| December 15, 2022 | 91365 | Class II | Ongoing | Oxford Partial Knee System, Fixed Lateral Tibial Construct- Intended to replace part of a knee joint when used in conjunction with a femoral and tibial component Item Number: 154341 | Packaged in the incorrect shelf carton. Incorrect shelf carton; outer carton is smaller than the required outer carton, which forces the Tyvex pouch to be folded and packaged in the carton causing compound creases and compromise the sterile barrier | accessdata.fda.gov |
| November 29, 2022 | 91423 | Class II | Ongoing | OSS Modular Arthrodesis Nail, 7 Degree Collar Assembly with Locking Bolts-For use in the replacement of segmental defects of long bone, including midshaft replacement, and arthrodesis of the knee Item Number: CP260602 | Product missing the four small locking collar bolts resulting in extension of surgery to find a replacement | accessdata.fda.gov |
| February 14, 2022 | 89701 | Class II | Terminated | BIOMET Sports Medicine JUGGERLOC SLOTTED REAMER: [Item # 110010371, 6MM], [Item #110010372, 7MM], [Item # 110010373, 8MM], [Item #110018275, 5MM]. Devices are packaged in a vacuum sealed nylon pouch, which is placed in a | Packaging of various implants may not have sufficient adhesion on all sides, leading to loss of sterile barrier integrity. Use of product poses risk of infection, leading to surgical intervention, and/or extension of surgery to find another part. | accessdata.fda.gov |
| January 7, 2022 | 89544 | Class II | Terminated | Arcos Modular Revision Hip System, Standard Cone Prox Body, Porous Plasma,Size A, 60 MM Item Number: 11-301301 | The products in scope underwent an incorrect rework operation for the porous plasma sprayed coating. Internal testing indicated that the parts may not have sufficient adhesion strength. The scope was identified to be all lots that were porous plasma coated or recoated at a vendor that were then reworked through the internal waterjet rework process. The water | accessdata.fda.gov |
| June 2, 2021 | 88304 | Class II | Terminated | Arcos Modular Revision Hip System Standard Cone Prox Body, Size A, 50 MM Item Number: 11-301300 | Arcos Proximal Cone Bodies could potentially exhibit chatter in the inner taper fretting corrosion and device failure in vivo leading to surgical intervention | accessdata.fda.gov |
| January 15, 2021 | 87201 | Class II | Terminated | Central Screw 6.5x25mm - Product Usage: used as a sterile screw that is intended for implantable shoulder prosthesis assembly and/or fixation. | Zimmer Biomet is conducting a lot specific medical device recall for the Comprehensive Reverse Shoulder Central Screw, 25 MM Length. It has been determined through a complaint investigation that a 40 MM length central screw was packaged and labeled as a 25 MM length central screw. | accessdata.fda.gov |
| December 23, 2020 | 87095 | Class II | Terminated | A.L.P.S. Clavicle Plating System, Plate, Fixation, Bone, Item Number 233500004 - Product Usage: indicated for fixation of fractures, osteotomies and non-unions of the clavicle including osteopenic bone. | The instruments may become cold welded together when the drill is inserted through the Soft Tissue Guide. This prevents disassociation of the instruments and potentially leads to an increased chance of fracture of the drill. | accessdata.fda.gov |
| December 1, 2020 | 86923 | Class II | Terminated | Vanguard 360 Revision System Posterior Augment With Bolt - Product Usage: intended for use in knee arthroplasty Item Number: 185422 | Incorrect bolt -tibial bolts in package instead of femoral bolts may delay procedure | accessdata.fda.gov |
| November 25, 2020 | 86896 | Class II | Terminated | 3.0mm Cannulated Screw System, BCS Cannulated Screw System (3.0, 4.0/5.0, 6.5/8.0mm), Item numbers 110009787 110009790, 110009794, 110009796, 110009798, 110009800 - Product Usage: Fracture fixationof small bones, small b | Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach in the packaging seal could lead to loss of sterility of the device. | accessdata.fda.gov |
| September 4, 2020 | 86424 | Class II | Terminated | Biomet Regenerex Primary Taper Cap Item Number 141269 | Product not properly being aligned with the adequate gamma sterilization group and result in the product not being properly sterilized | accessdata.fda.gov |
| September 3, 2020 | 86382 | Class II | Terminated | (1) RingLoc Bi-Polar Hip System Acetabular Cup ArCom: Acetabular Bi-Polar Cup, E1 Antioxidant Infused, 28 MM, 41 MM: Item No. 110010458; Lot No. 710930; UDI No. (01) 00880304568747 (17) 230614 (10) 710930 (2) RingLoc Hip | Zimmer Biomet is conducting a medical device recall for three lots of the RingLoc Bi-Polar Hip system Acetabular Cup. The affected lots were gamma sterilized twice. Sufficient data does not exist to support the functionality, shelf life, or package integrity for more than one-time sterilization. | accessdata.fda.gov |
| September 2, 2020 | 86422 | Class II | Terminated | Biomet Comprehensive Reverse Shoulder Glenosphere Mini Baseplate with Taper Adapter-Shoulder Prosthesis item: 010000589 - Product Usage: intended to serve as the foundation for the reverse shoulder prosthesis head (gleno | Product potentially being packaged without a taper adapter or baseplate. The package should contain one (1) baseplate and one (1) taper adapter, product may be packaged with two (2) baseplates and no (0) adapters or with no (0) baseplates and two (2) adapters | accessdata.fda.gov |
| May 11, 2020 | 85658 | Class II | Terminated | Comprehensive VRS Inserter, shoulder prosthesis, Item No. 110019068. UDI: (01)00880304829503 (10)814100, (01)00880304829503 (10)570640, (01)00880304829503 (10)728890, (01)00880304829503 (10)977300 | The product is being recalled due to the central screw drill seizing inside the Comprehensive VRS Inserter, which may lead to an extension of surgery to find a replacement device. | accessdata.fda.gov |
| April 17, 2020 | 85524 | Class II | Terminated | Extremities Item Number: 1)113954 Hybrid Glenoid Glenoid Base, 4 MM 2) XL-115366 Comprehensive Reverse Shoulder Humeral Bearing, ArComXL, 44 MM X 41 MM, Standard 3) XL-115364 Comprehensive Reverse Shoulder Humeral Bearin | Potential presence of elevated endotoxin levels that exceed the specification limit | accessdata.fda.gov |
| March 13, 2020 | 85272 | Class II | Terminated | Comprehensive Humeral Tray Taper Extraction Pliers - Replacement Tips, Model Number 110028522 - Product Usage: Intended to be used in surgery to relieve pain and to replace the glenoid and humeral side of the shoulder jo | There were unknown bioburden levels prior to sterilization, which may affect sterility of the product. | accessdata.fda.gov |
| February 26, 2020 | 85153 | Class II | Terminated | BIOMET StageOne Hip Cement Spacer Mold with Insert, 48 MM, Silicone, Sterile, Item 431181. | Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters. | accessdata.fda.gov |
| February 25, 2020 | 85143 | Class II | Terminated | Biomet Comprehensive Reverse Shoulder Glenosphere Mini Baseplate With Taper Adapter-indicated for primary, fracture, or revision total shoulder replacement for the relief of pain and significant disability due to gross r | Package is intended to contain one (1) baseplate and one (1) taper adapter; however, devices may be packaged with two (2) baseplates and no (0) adapters. | accessdata.fda.gov |
| February 17, 2020 | 85073 | Class II | Terminated | Comprehensive Shoulder System Mini Humeral Stem 9mm,, Model No. 113629 - Product Usage: The intended use of the comprehensive humeral stem mini is to act as the humeral component of the comprehensive total shoulder syste | A 15mm Shoulder Mini Humeral Stem was misidentified as a 9mm Shoulder Mini Humeral Stem. | accessdata.fda.gov |
| January 7, 2020 | 84753 | Class II | Terminated | THP Hip Plating System, Item Nos. 14-451070 14-451075 14-451080 14-451085 14-451090 14-451095 14-451100 14-451105 14-451110 14-451115 14-451120 14-451125 14-451130. The product is a metallic bone fixation system. | Potential increase in fracture rate was detected during internal testing, in addition to potential discoloration inside the inner pouch of the packaging. | accessdata.fda.gov |
| December 19, 2019 | 84598 | Class II | Terminated | ASI 2.0 Calcar Trimmer Shaft for Use with Zimmer Rasp Mode Number: 110032332 Product Usage: The device is a general orthopedic manual surgical instrument | Potential issue associated with the instrument -end of the shaft could fail to effectively mate with the broach | accessdata.fda.gov |
| October 25, 2019 | 84224 | Class II | Terminated | Biomet Orthopedics Intramedullary Bone Saw Cam Assembly 13MM-Orthopedic manual surgical instrument Item Number: 475660 | Possible commingle of 13 MM and 14 MM Intramedullary Bone Saw Cam Assembly -an Intramedullary Bone Saw Cam Assembly was labeled and etched as a 14 MM but measured as a 13 MM cam | accessdata.fda.gov |
| August 21, 2019 | 83783 | Class II | Terminated | Compress, Mini Compress; Item Nos. 178350 178351 178352 178353 178354 178355 178356 178357 178358 178359 178360 178361 178362 178363 178364 178365 178366 178367 178368 178369 178370 178371 178372 178373 178464 178472 178 | Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning issue. | accessdata.fda.gov |
| August 15, 2019 | 83594 | Class II | Terminated | XP- CR Tibial Tray- Interlok 59mm Item # 195268 | The locking bar not fully engaging | accessdata.fda.gov |
| August 6, 2019 | 84124 | Class II | Terminated | ASI 2.0 Calcar Trimmer Shaft for Use with Biomet Rasp, Model Number 110032331 | The potential that the end of the shaft could fail to effectively mate with the broach with the Calcar Planar Shaft instrument, part number 110032331. | accessdata.fda.gov |
| July 2, 2019 | 83314 | Class II | Terminated | Orthopedic Salvage System (OSS) Hybrid Poly Tibia Item # 151810 | Cleaning processes potentially being ineffective | accessdata.fda.gov |
| June 10, 2019 | 83099 | Class II | Terminated | Comprehensive Reverse Shoulder Instrument Case Outer (Outer Case Vault Only), Item Number 595509 | Lack of an adequate sterilization validation. | accessdata.fda.gov |
| June 4, 2019 | 83085 | Class II | Terminated | Ultra-Drive Hose/Drape Assembly, Reference Number 423833 - Product Usage: Item used with the UltraDrive System to provide proper irrigation during the cutting and removal of bone and acrylic bone cement in orthopedic app | The products do not have sufficient data to support the labeled shelf life of 10 years. | accessdata.fda.gov |
| May 28, 2019 | 83024 | Class II | Terminated | DVR Crosslock ePAK Screw Driver, Model Number 212000002 Product Usage: These DVR Express Disposable Instruments are used to facilitate implantation of orthopedic medical devices in trauma. | There is a potential for weak seals of the sterile packaging. | accessdata.fda.gov |
| April 1, 2019 | 83004 | Class II | Terminated | Mobi-C 14mm Distraction Screw, Quick Start. Intended for cervical intervertebral disc replacement. Item Number: 0024-LDR TEDAN SURGICAL INNOVATIONS LLC DISTRIBUTED BY: LDR SPINE USA, INC., 13785 RESEARCH BLVD, SUITE 200- | Incorrect part description contained on an additional label placed on the packaging: A 14mm length part was incorrectly labeled as being a 12mm length screw | accessdata.fda.gov |
| March 28, 2019 | 82640 | Class II | Terminated | T7 Driver Cannulated AO (Part Number 110018531) Product Usage: The Biomet Headless Compression Screws and Twist-Off Screws are indicated for fixation of bone fractures, fusion of a joint (arthrodesis) or bone reconstruct | There is a potential of fracture, bending or shearing of the driver. | accessdata.fda.gov |
| March 1, 2019 | 82332 | Class II | Terminated | Biomet RingLoc Hip System Self-Tapping Bone Screw 6.5mmx20mm-Low Profile Titanium. Accessory to total hip implant Item Number: 103531 Product Usage: Accessory to total hip implant | Two lengths of the 6.5mm RingLoc Hip System Self-Tapping Bone Screw may have the potential for the 30mm screws to be packaged as 20mm screws and vice versa. | accessdata.fda.gov |
| February 28, 2019 | 82324 | Class II | Terminated | Biomet Small Diameter Cement Plug Inserter-Sterile, single-use accessory instrumentation to be used during surgical procedures utilizing the Small Diameter Cement Plug implant devices Item Number: 414989 | Lack of an adequate sterilization validation | accessdata.fda.gov |
| December 21, 2018 | 82004 | Class II | Terminated | Vanguard Knee System Series-A Standard Patella sizes 31mm Item Number: 184764 | Vanguard Knee System Series-A Standard Patella a potential commingle that could result in the size of the implant not matching the size on the label. | accessdata.fda.gov |
| December 21, 2018 | 81118 | Class II | Terminated | Comprehensive Reverse Shoulder System Glenosphere Mini Baseplate with Taper Adapter, Model Number 010000589 Biomet Comprehensive Reverse Shoulder products are indicated for use in patients whose shoulder joint has a gros | The product was potentially being packaged without a taper adapter. | accessdata.fda.gov |
| November 28, 2018 | 81758 | Class II | Terminated | Maximum Variable Pitch Compression Tray Base, Reference Number 231201002 Product Usage: Intended to carry implants and instruments during regular inventory distribution and handling and sterilization in the hospitals | There is a potential for silicone shedding during cleaning and sterilization. | accessdata.fda.gov |
| November 20, 2018 | 81704 | Class II | Terminated | Biomet DVR Crosslock Screws- 2.7mm x 20mm, Sterile ITEM 131827120 Product Usage: The system is intended for stabilization and fixation of small bone fragments in fresh fractures, revision procedures, joint fusion and rec | One lot of product labeled 2.7mm x18mm Lock Screw Square Drive (Lot 029970) contains 20mm locking screws and one lot of product labeled 2.7mm x 20mm Lock Screw Square Drive (Lot 029980) contains 18mm locking screws | accessdata.fda.gov |
| October 24, 2018 | 81513 | Class II | Terminated | Biomet 20mm Compress Device Short Anchor Plug With Drill Set / With Pin Inserter Ion Implant Item number: 178562 Product Usage: 1. Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacem | Potential metal burrs in the holes of the device preventing the appropriate drill and transverse pins from being inserted | accessdata.fda.gov |
| October 22, 2018 | 81472 | Class II | Terminated | Vanguard Knee System -PS Open Box Femoral Left, 62.5 mm Item Number: 183126 | Label on the outer carton or the patient labels does not match label on the inner sterile packaging | accessdata.fda.gov |
| October 12, 2018 | 81404 | Class II | Terminated | Zimmer Compress Devices and Instruments: Item Number/Item Description 178350 Compress Device Anti-Rotation Spindle 178353 Compress Device Anti-Rotation Spindle 178356 Compress Device Anti-Rotation Spindle 178359 Compress | Correction to update the surgical technique for the Compress System. To make users aware of the changes that were made only to the selection criteria section on page 42 regarding which array to use in the placement of the anti-rotation pins. | accessdata.fda.gov |
| October 10, 2018 | 81528 | Class II | Terminated | Orthopedic Salvage System (OSS) Porous Stem, Item No. 150394 | Zimmer Biomet is conducting a lot specific medical device recall for two lots of the Orthopedic Salvage System (OSS) and the Comprehensive Shoulder System. The investigation determined that the Mini Humeral Stem is potentially labeled as the Bowed IM Stem lot. The associated risk of this product issue is a potential extension of surgery <30 minutes if a repl | accessdata.fda.gov |
| October 2, 2018 | 81223 | Class II | Terminated | Affixus Hip Fracture Nail Left Deg 9x300mm, Item Number 814609300 The Affixus Hip Fracture Nail System, comprised of short and long nails, provides surgeons with an intramedullary hip screw to stabilize fractures of the | The set screw is not able to advance or reverse from the original position in the nail. | accessdata.fda.gov |
| September 21, 2018 | 81185 | Class II | Terminated | StageOne Hip, Models 431207 & 431209Usage: Product Usage: The single-use cement spacer molds are sterile disposables made of medical grade silicone with a 316L stainless steel reinforcement stem. They are designed to be | There is a potential for comingling of the 43MM and 51 MM molds | accessdata.fda.gov |
| August 22, 2018 | 81072 | Class II | Terminated | Biomet Microfixation RapidFlap System 12mm SpinDown Clamp, sterile Ref Number: 75-1020 Used for the re-attachment of the bone flap after a craniotomy. | Spin Down RapidFlap nut that interfaces with the outer plate was assembled incorrectly. | accessdata.fda.gov |
| August 8, 2018 | 81038 | Class II | Terminated | Affixus Hip Fracture Nail 125 9 mm x 180 mm, Item Number 814309180 Product Usage: Intended for the fixation of fractures | There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open. | accessdata.fda.gov |
| August 3, 2018 | 80918 | Class II | Terminated | Biomet Sports Medii cine Juggerknot Long Flex Drill Bit with Sleeve Nitinol intended to be used for soft tissue to bone fixation with indications for use in: Shoulder, Foot and Ankle, Knee, Hand and Wrist and Hip repair. | Expiration date incorrectly listed on the label | accessdata.fda.gov |
| August 2, 2018 | 80904 | Class II | Terminated | Vanguard 360 Revision Knee System 63x 10mm Universal Tibial Block Augment, Model Number 185221 Intended for use in Total Knee Arthroplasty | The implant only has one bolt in the sterile package but it should have had two. | accessdata.fda.gov |
| July 20, 2018 | 80843 | Class II | Terminated | Gentle Thread PLGA Round Head Interference Screw, 7x20mm, Item Number 905612 | The Gentle Thread PLGA Round Head, 7x20mm and the Gentle Thread PLGA Full Thread 10x30 have been commingled. | accessdata.fda.gov |
| July 17, 2018 | 80755 | Class II | Terminated | Affixus Hip Fracture Nail Right 125 9 mm x 280 mm, Item Number: 814309280 | The set screw is not able to advance or reverse from the original position in the nail. | accessdata.fda.gov |
| July 12, 2018 | 80731 | Class II | Terminated | Peg Fully Threaded, Locking, 2.5mm x 10mm, Item Number 131212610 Orthopedic device used for stabilization and fixation of small bone fragments Intended for stabilization and fixation of small bone fragments in fresh frac | A size 22mm threaded peg was found in the package of a 10mm unit. | accessdata.fda.gov |
| June 22, 2018 | 80548 | Class II | Terminated | Persona Partial Knee System Spacer Block Alignment Tower, Item No. 42-5399-006-35 Product Usage: Intended to aid in preparatory surgical procedures | The PPK System Spacer Block Alignment Tower mating feature that mates with the spacer block was undersized, which could potentially lead to mating issues between the devices. This could cause a delay in surgery of less than 30 minutes. There is an option in the surgical technique for performing limb alignment without the alignment tower. | accessdata.fda.gov |
| June 18, 2018 | 80543 | Class II | Terminated | Connecting Bolt, Model 14-442093 | Product was manufactured from the incorrect material, which shows a potential decrease in the fatigue strength of the connecting bolt that can lead to fracture. | accessdata.fda.gov |
| June 8, 2018 | 80534 | Class II | Terminated | ARCOS Modular Revision Hip System, item number 11-300814 orthopedic hip prosthesis femoral stem. | Two lots of the Echo BI-Metric Hip Stem and ARCOS Modular Revision Hip Stem may have been comingled. Potential health consequences include extension of surgery time to find a replacement component. | accessdata.fda.gov |
| May 24, 2018 | 80186 | Class II | Terminated | Vanguard Complete Knee System; E1 Vanguard PS Tibial Bearing; Model Numbers EP-183664, EP-183642 Product Usage: The product is intended for use in knee joint replacement arthroplasties. | Two lots of tibial bearings were commingled. There is a possibility that a 14mm tibial bearing is packaged in a box labeled as 12 mm tibial bearing and vice versa. This may lead to extension of surgery to find another implant. | accessdata.fda.gov |
| May 18, 2018 | 80185 | Class II | Terminated | Biomet Modular Primary Tibial Tray Implants; Modular Interlok Primary Tray (size 75 mm); Item No. 141215; UDI: (01) 00880304005310 (17) 280306 (10) 385340 Product is used in Total Knee Arthroplasty | One lot of 75mm tibial tray is potentially etched and labeled as a 79 mm tibial tray. This may lead to delay in surgery, or immediate revision surgery to remove an incorrectly sized tibial component after it has been cemented. | accessdata.fda.gov |
| May 16, 2018 | 80193 | Class II | Terminated | DRILL PT GUIDE WIRE 3.2MMX98CM, 469360 Intended to be used as a guide pin for insertion of implants (cannulated screws and/or intramedullary nails). Bone nail guidewire. Intended for drilling bone. | The firm is recalling various trauma guide wires due to insufficient packaging design verification and exceeding the expected occurrence rate of complaints for sterile barrier failure. Guide wires packaged in the affected packaging configuration have the potential for sterile barrier breach, leading to possible risk for infection. | accessdata.fda.gov |
| May 11, 2018 | 80172 | Class II | Terminated | Vanguard Knee System PS Tibial Bearing, Part Number 183621 Intended for use in knee joint replacement procedures. | The label master file was errantly set up as a 63/37mm instead of a 63/67mm. There is no 63/37 size offered, and the product is laser marked with the correct size. | accessdata.fda.gov |
| April 5, 2018 | 79987 | Class II | Terminated | Lactosorb RapidFlap, bone plate, Model No. The RapidFlap LS Cranial Fixation System is indicated for use in pediatric craniotomy flap fixation. | The recalling firm has confirmed that the Outer Plate component exhibits an excessive chamfer on the threading after deburring operations. This excessive chamfer results in non-conforming product where the threads of the outer plate component have limited to no engagement with the post component. | accessdata.fda.gov |
| April 3, 2018 | 79692 | Class II | Terminated | Orthopedic Salvage System (OSS) Modular Arthrodesis 0 Degree Locking Collar, Model Number CP260600 Product Usage: The replacement of segmental defects of long bone, including midshaft replacement, and arthrodesis of the | There is a potential dry blast irregularity on the locking collar screws packaged with the locking collar. | accessdata.fda.gov |
| April 2, 2018 | 79685 | Class II | Terminated | Modular Head Component, Biomet Hip System; Item No. 163669, Hip Joint, metal/polymer semi-constrained cemented prosthesis The device is used in treatment of patients who need total hip arthroplasty, and consists of modul | Two lots of different sized modular heads potentially commingled. Risks include delay in surgery and dislocation due to use of an incorrect sized head. | accessdata.fda.gov |
| March 28, 2018 | 79682 | Class II | Terminated | Gentle Threads, Interference Screw; Model No. 905617, for soft tissue reattachment procedures in the ankle/foot and knee. | Specific lots of the device were overexposed during EtO sterilization. This may lead to revision due to infection from loss of sterile barrier during over-exposure cycle. | accessdata.fda.gov |
| March 12, 2018 | 79487 | Class II | Terminated | Phoenix Nail System, intended for use with an intramedullary nail system for alignment, stabilization and fixation of fractures. 3.5mm Inserter Connector, Short; Model Number: 14-441045; Kit Model Numbers: 14-400082, 14- | Certain lots of the Phoenix Tibia Nail 3.5mm Inserter instruments are being recalled due to reports of fracturing and remaining in the device implant. | accessdata.fda.gov |
| February 28, 2018 | 79399 | Class II | Terminated | Zimmer Biomet Comprehensive Segmental Revision System (SRS). Orthopedic implants for Proximal Humeral Reconstruction, Distal Humeral Reconstruction, and Total Humeral Reconstruction | During assembly, an SRS Humeral Distal Body implant failed to engage correctly at the point of reduction with a Discovery Elbow System Humeral Condyle. A mismatch between the screw holes in the Humeral Body & Elbow Condyle affects assembly during surgery. If the product has already been implanted, no action is required. The mismatch is estimated to prevent s | accessdata.fda.gov |
| February 6, 2018 | 79409 | Class II | Terminated | AIM Tibial Nails intramedullary fixation rod - STERILE; Item numbers: 800508255 NAIL TIB DYN 08X25.5 - STERILE 800508270 NAIL TIB DYN 08X27.0 - STERILE 800508285 NAIL TIB DYN 08X28.5 - STERILE 800508300 NAIL TIB DYN 08X3 | The AIM Tibial Nails failed a clinical analysis where the surgical revision rate exceeded the acceptance criteria in the Device Performance Review protocol for the implant system. | accessdata.fda.gov |
| December 20, 2017 | 79408 | Class II | Terminated | ACE Trochanteric Nail System ACE TROCH NAIL 125 DEG. X 11MM ACE TROCH NAIL 130 DEG. X 11MM ACE TROCH NAIL 135 DEG. X 11MM ACE TROCH NAIL 125 DEG. X 13MM ACE TROCH NAIL 130 DEG. X 13MM ACE TROCH NAIL 135 DEG. X 13MM The T | Zimmer Biomet is conducting a medical device recall for the ACE Trochanteric Nail (ATN) system after a Device Performance Review (DPR) failed clinical analysis for survivorship pursuant to the acceptance criteria for the DPR protocol for the ATN system. | accessdata.fda.gov |
| December 8, 2017 | 79385 | Class II | Terminated | Humeral Stem 83mm(Size 17) Product Usage: Intended for primary and revision total shoulder arthroplasty as well as hemi-arthroplasty | Zimmer Biomet is conducting a medical device recall for two lots of Comprehensive Humeral stems. The lots were commingled during the manufacturing process and were etched with incorrect lot numbers. The size difference between the two stem sizes is 1.1 inches. It is visually recognizable by the user that the box label does not match the contents of the box. | accessdata.fda.gov |
| December 7, 2017 | 79387 | Class II | Terminated | 6.5mm x 125mm x 16mm Cannulated Screw, Item Number: 110009948 (UDI: (01)00887868111327 (17)270421 (10)120910) Product Usage: The 6.5/8.0mm Cannulated Screw System is part of a series of cannulated screws ranging from 4.0 | One lot of 3.5mm x 24mm Cortical Locking screws is labeled as 6.5mm x 125mm x 16mm Cannulated screws. | accessdata.fda.gov |
| November 29, 2017 | 79383 | Class II | Terminated | Persona Partial Knee spacer block instruments; (1) 8mm block, Model Number: 42-5399-035-08; (2) 9mm block, Model Number:42-5399-035-09; (3) 10mm block, Model Number: 42-5399-035-10; (4) 12mm block, Model Number: 42-5399- | Certain partial knee implant spacer blocks do not fit in the alignment tower instrument or handle. | accessdata.fda.gov |
| October 25, 2017 | 79393 | Class II | Terminated | A.L.P.S. MIS Calcaneus Locking Plate LG RT F.A.S.T. Guide inserts, Item Number: 816209003,UDI: 00887868044670989403 | The drill guides were manufactured with the incorrect color anodization. | accessdata.fda.gov |
| October 25, 2017 | 79273 | Class II | Terminated | fastener, fixation, nondegradable, soft tissue | It was identified that the product was not assembled correctly causing the implant shaft to shift and fall out during the opening of the device, which potentially could break the device. | accessdata.fda.gov |
| October 24, 2017 | 79395 | Class II | Terminated | Persona Partial Knee Spacer Blocks To assist in partial knee arthroplasty surgery | Zimmer Biomet is conducting a medical device recall for the Persona Partial Knee Spacer Blocks in sizes 8mm, 9mm, 10mm, 12mm, and 14mm. Complaints received indicated that flexion has the potential to feel tight during range-of-motion trialing and that the final trial has the potential to appear looser in extension. | accessdata.fda.gov |
| October 11, 2017 | 79263 | Class II | Terminated | TunneLoc Tibial Fixation Device Product Usage: To provide fixation of soft tissue grafts within the tibial tunnel during anterior cruciate ligament (ACL) and/or posterior cruciate ligament (PCL) reconstruction. | Gamma sterilization validation testing indicates the sterilization dose for the product may not be adequate. | accessdata.fda.gov |
| October 3, 2017 | 79250 | Class II | Terminated | Vanguard CR Porous Femoral 62.5mm (Left Femur) For use in total knee arthroplasty | The affected products are labeled as a 62.5mm LEFT Femur; however, the contents are a Vanguard 70mm RIGHT Femur. | accessdata.fda.gov |
| September 29, 2017 | 79161 | Class II | Terminated | Vanguard Complete Knee System, Vanguard CR Tibial Bearing 12x71/75, Item Number: 183442 Product Usage: For use in total knee arthroplasty | Knee implant components (tibial bearings) are labeled with the incorrect size. | accessdata.fda.gov |
| September 15, 2017 | 79254 | Class II | Terminated | 36MM COCR MODULAR HD -6MM | One piece from a different lot mixed with lot 236840 and is incorrectly etched as -6MM offset instead of +3MM offset. As the incorrect etching and related size difference affects the functional use of this product, the affected lot is being removed from the field. | accessdata.fda.gov |
| September 13, 2017 | 79146 | Class II | Terminated | Phoenix Antegrade Femoral Nail Trochanteric and Piriformis fossa, Model#14-442093 Antegrade Femoral Connecting Bolt. orthopedic instrument | Fracture of the bolt connecting the insertion guide to the intramedullary nail during insertion of the femoral nail. | accessdata.fda.gov |
| September 11, 2017 | 79082 | Class II | Terminated | BlockAid Cut Resistant Surgical Glove Liners, combine stainless steel and synthetic fibers woven together to form a cut resistant glove material. Blockaid Cut Resistant Surgical Glove Liners are to be worn between two la | Cut resistant surgical glove liners lack sterility assurance. | accessdata.fda.gov |
| September 7, 2017 | 79141 | Class II | Terminated | The 2nd Assist Knee Positioner | Zimmer Biomet is conducting a medical device recall for the 2nd Assistant Knee Positioner due to the potential for the sterile packaging barrier to be breached during distribution. | accessdata.fda.gov |
| August 28, 2017 | 79103 | Class II | Terminated | Persona Partial Knee System Product Usage: The Persona Partial Knee System instruments are used by a surgeon to facilitate the implantation of PPK implantable components into the medical knee compartment during unicondyl | Potential for the Persona Partial Knee Impactor Pad to fracture. | accessdata.fda.gov |
| August 25, 2017 | 79104 | Class II | Terminated | G7 DUAL MOBILITY LINER 44MM F Product Usage: Intended for use in hip arthroplasty cases which involves the removal of the damaged joint and tissues to be replaced with artificial prosthesis. The result of the procedure i | The affected products are labeled and etched as F-44 mm liners; however, the physical products could potentially be E-42 mm liners. | accessdata.fda.gov |
| August 25, 2017 | 79095 | Class II | Terminated | AGC 2000 LP Patella, labeled as AGC Porous Patellar SM, Model Number 150802. Product Usage: For use in Total Knee Arthroplasty. | The affected AGC 2000 LP Patella products were over-molded leaving the outside diameter nonconforming to the print dimension. | accessdata.fda.gov |
| August 22, 2017 | 79105 | Class II | Terminated | Ziptight Ankle Syndesmosis Fixation Device, Titanium Implant Titanium Implant for surgical repairs of soft tissue. | Ziptight Ankle Syndesmosis Fixation was packaged without the tip protectors. | accessdata.fda.gov |
| August 7, 2017 | 78763 | Class II | Terminated | Affixus Hip Fracture Nail, 125 DEG 11MM X 180MM | During the rework process for the April 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an interference fit, were no longer in the installed location. This could prevent the product assembly with the mating screw and targeting jig. | accessdata.fda.gov |
| July 5, 2017 | 78725 | Class II | Terminated | Persona Partial Knee System, Size 8, Finishing Guide | Finishing guide does not adequately account for shape differences present in Size 8 of Persona Partial Knee System, potentially resulting in additional surgery time or sensation of tightness during knee flexion. | accessdata.fda.gov |
| June 30, 2017 | 79242 | Class II | Terminated | DELTA CER FEM HD 32/0MM T1 Product Usage: For use in hip arthroplasty | Product may contain the presence of melted sterile packaging upon opening. | accessdata.fda.gov |
| June 29, 2017 | 78758 | Class II | Terminated | PPS RingLoc+ Acetabular Shell, RNGLC+ LTD HOLE SHELL SZ62 The Porous Plasma Spray (PPS) Ringloc+ Acetabular System is intended to replace the natural acetabulurn damaged by disease, trauma or revision of previous arthrop | Device was distributed with the etching missing from the product. | accessdata.fda.gov |
| June 16, 2017 | 78705 | Class II | Terminated | ExploR Radial Head Replacement System. PN: 11-210061 LN: 243610. The stem is placed inside a polyurethane bag. The bagged component will then be placed in an inner PETG tray. The screw will be placed inside a separate po | Zimmer Biomet is conducting a medical device recall for the ExploR 6x24mm Implantable Stem with Screw due to a complaint alleging that the Modular Radial HD lock screw was not included in the package for the stem. | accessdata.fda.gov |
| June 12, 2017 | 77594 | Class II | Terminated | DRILL BIT MINI QUICK CONNECT 1.0MM, REF 2312-20-200 & 2312-20-202, NON STERILE | A raw material anomaly was discovered in four lots of raw material and has the potential to be on or below the surface of the device components which can increase the risk of instrument fracture | accessdata.fda.gov |
| June 5, 2017 | 78167 | Class II | Terminated | Lateral Troch Plate Full Crimp - 254mm, model # 350837 | Possibility that the patient label inside the product box was incorrectly labeled. The outer box label and actual product are correctly identified but the internal patient label could be incorrect. | accessdata.fda.gov |
| May 1, 2017 | 78944 | Class II | Terminated | ROSA Brain 3.0 Stereotaxic instrument Computer-assisted surgical device. Intended for the spatial positioning and orientation of instrument holders to be used by neurosurgeons. | Robot arm being sent to the wrong position | accessdata.fda.gov |
| April 26, 2017 | 77119 | Class II | Terminated | Modular Hybrid Glenoid Base Large for the Comprehensive Shoulder System, The product is placed into an AlOx coated PET pouch and vacuum sealed with an Argon flush. The vacuum sealed product is then placed into a Tyvek/fi | Zimmer Biomet is conducting a voluntary recall for a single lot of the Modular Hybrid Glenoid Base Large for the Comprehensive Shoulder System after it was determined that two pieces from the lot were moved to finished goods and shipped despite having an open Non-Conformance Report (NCR). The NCR indicated that one piece from the lot had scratches and the ot | accessdata.fda.gov |
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- All makers of Rod, Fixation, Intramedullary And Accessories
- All makers of Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component)
Updated October 6, 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.