Data / Medical devices / United States / Zimmer Manufacturing B.V.
Zimmer Manufacturing B.V.: FDA-registered device maker in Mercedita, PR, United States, 34 510(k) clearances
Zimmer Manufacturing B.V. is registered with the FDA (registration 2648920) in Mercedita, PR, United States. It lists 23 device types. The FDA files 34 510(k) clearances under its listings, the newest dated December 10, 2021. 8 recall events name it as the recalling firm. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 2648920
- FEI number
- 1000132037
- Address
- Route 1, KM. 123.4, BLDG. 2 Turpeaux Industrial Park, Mercedita, PR, United States, 00715
- Owner or operator
- ZIMMER, INC. (1822565)
- Roles
- Contract manufacturer, Manufacturer, Manufacturer for export
- First device listed
- May 22, 2001
- Registered through
- 2027
- Brand names listed
- (Ti-6Al-4V Alloy, CP Grade Titanium, 3.5MM PLATES AND SCREWS-4936 PLATES, 4835 SCREWS, Alpha System, Beta Hip Prosthesis, Bipolar Hip Device, CO-CR-MO Alloy Femoral, CPT Stainless Steel Hip 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.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| December 10, 2021 | K210842 | VerSys Cemented Revision/Calcar | JDI | 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 |
| November 5, 2019 | K183457 | Zimmer Biomet 12/14 CoCr Femoral Head and Freedom Head | LPH | Substantially Equivalent | Zimmer, Inc. | 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 |
| November 24, 2015 | K152841 | Zimmer Plates and Screws System (ZPS) Sterile 2.7mm Cortical Screws | HWC | 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 |
| 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 |
| 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 |
| August 14, 2014 | K140508 | ZIMMER PLATES AND SCREWS SYSTEM(ZPS)- NON-STERILE PLATES AND SCREWS | HRS | Substantially Equivalent | Zimmer, Inc. | accessdata.fda.gov |
| November 7, 2012 | K121771 | ZIMMER PERSONA THE PERSONALIZED KNEE SYSTEM | MBH | Substantially Equivalent | Zimmer, Inc. | accessdata.fda.gov |
| March 27, 2012 | K113369 | ZIMMER PERSONA KNEE SYSTEM | JWH | Substantially Equivalent | Zimmer, Inc. | accessdata.fda.gov |
| December 19, 2011 | K112885 | ZIMMER PLATES AND SCREWS SYSTEM SCREWS ONLY | HWC | Substantially Equivalent | Zimmer, Inc. | accessdata.fda.gov |
| October 5, 2011 | K111447 | ZIMMER PERIARTICULAR SCREWS | HWC | Substantially Equivalent | Zimmer, Inc. | accessdata.fda.gov |
| February 26, 2009 | K083654 | ZIMMER UNIVERSAL LOCKING SYSTEM 2.7 MM LOCKING PLATES AND SCREWS ( TIVANIUM TI-6A1-4V ALLOY, CP GRADE TITANIUM) | HRS | Substantially Equivalent | Zimmer, Inc. | accessdata.fda.gov |
| December 18, 2008 | K082527 | ZIMMER UNIVERSAL LOCKING SYSTEM: 3.5 MM LOCKING PLATES AND SCREWS | HRS | Substantially Equivalent | Zimmer, Inc. | accessdata.fda.gov |
| April 26, 2006 | K060710 | UNIVERSAL LOCKING SYSTEM, 3.5MM PLATES AND SCREWS-4936 PLATES,4835 SCREWS | HWC | Substantially Equivalent | Zimmer, Inc. | accessdata.fda.gov |
| February 5, 2001 | K003478 | TRIOLOGY ACETABULAR SYSTEM 46MM LARGE HEAD LINERS, MODEL 6310 | LPH | Substantially Equivalent | Zimmer, Inc. | accessdata.fda.gov |
| December 11, 2000 | K002960 | TRILOGY ACETABULAR SYSTEM LARGE HEAD LINER, MODEL 6353 | LPH | Substantially Equivalent | Zimmer, Inc. | accessdata.fda.gov |
| July 12, 1999 | K990135 | TRILOGY ACETABULAR SYSTEM LONGEVITY CROSSLINKED POLYETHYLENE | LPH | Substantially Equivalent | Zimmer, Inc. | accessdata.fda.gov |
| January 9, 1997 | K963109 | HERITAGE HIP SYSTEM | JDI | Substantially Equivalent | Zimmer, Inc. | accessdata.fda.gov |
| July 25, 1996 | K960278 | COBALT-CHROMIUM-MOLYBDENUM (CO-CR-MO) ALLOY FEMORAL HEADS W/CO-NIDIUM SURFACE TREATMENT | JDI | Substantially Equivalent | Zimmer, Inc. | accessdata.fda.gov |
| February 16, 1996 | K955473 | GAMMA SYSTEM | JDI | Substantially Equivalent | Zimmer, Inc. | accessdata.fda.gov |
| January 22, 1996 | K953337 | BETA HIP PROSTHESIS | LPH | Substantially Equivalent | Zimmer, Inc. | accessdata.fda.gov |
| January 17, 1996 | K954698 | TRILOGY ACETABULAR COMPONENT 7MM OFFSET | LPH | Substantially Equivalent | Zimmer, Inc. | accessdata.fda.gov |
| October 20, 1995 | K953490 | TRILOGY ACETABULAR SHELL & LINERS 36MM | LPH | Substantially Equivalent | Zimmer, Inc. | accessdata.fda.gov |
| May 17, 1995 | K950312 | ALPHA SYSTEM | JDI | Substantially Equivalent for Some Indications | Zimmer, Inc. | accessdata.fda.gov |
| April 29, 1994 | K934765 | TRILOGY ACETABULAR SYSTEM | LPH | Substantially Equivalent | Zimmer, Inc. | accessdata.fda.gov |
| April 17, 1984 | K840643 | HARRIS-GALANTE POROUS TOTAL HIP SYS | JDI | Substantially Equivalent | Zimmer, Inc. | accessdata.fda.gov |
| January 30, 1984 | K833991 | BIPOLAR HIP DEVICE | KWY | Substantially Equivalent | Zimmer | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| May 4, 2016 | 73981 | Class II | Terminated | Zimmer Plates and Screws (ZPS) 3.5 mm Cortical Screw SelfTapping, 10 mm Length 47483501001 3.5 mm Cortical Screw SelfTapping, 14 mm Length 47483501401 3.5 mm Cortical Screw SelfTapping, 16 mm Length 47483501601 3.5 mm Co | A small hole may be present in the inner tray of specific lots of sterile Hip and Trauma Implant Screws. | accessdata.fda.gov |
| March 17, 2016 | 73498 | Class II | Terminated | Persona The Personalized Knee System Articular Surface Posterior Stabilized (PS) Left Height 14mm Sterile. For use in total knee arthroplasty. REF 42-5114-005-14 | The firm received a customer complaint establishing that the product (Persona PS Articular Surfaces)information shown on the box differed by sides. One side showed P/N: 42-5114-008-18/ Lot: 62632101 and the other side showed P/N: 42-5114-005-14/ Lot: 62646580. | accessdata.fda.gov |
| January 11, 2016 | 72900 | Class II | Terminated | Product 1 consists of all product under, product code: JWH and same usage: Item no: 47481500601 1.5 X 6 CORT SCREW HEX/SE Product Usage: A smooth or threaded metallic bone fixation fastener is a device intended to be imp | As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013. The affected products are sterile. | accessdata.fda.gov |
| December 3, 2015 | 72750 | Class II | Terminated | NexGEN System REF 5980-37-01 Tibial Component Size Stemmed 3 Precoat, and REF 5986-37-01 Nonaugmentable Tibial Component Option CR/PS/LPS Size Stemmed 3. Tibial component of implanted knee prosthesis. | A product complaint was received stating that a carton labeled as a Precoat Stemmed Tibia Size 3 was opened for use and the contents were a non-augmented Stemmed Tibia Plate size 3. | accessdata.fda.gov |
| December 2, 2015 | 72729 | Class II | Terminated | Label reading in part as: "NexGen System, Complete Knee Solution; Reference Number 5980-37-01; Tibial Component, Precoat, Stemmed Size 3; Lot Number:62460264. Indicated for patients with severe knee pain and disability a | Complaints were received from Thailand reporting that there was no white paper (Tyvek) seal on the inner package of P/N:00-5980-037-01 unit from lot #62460264 | accessdata.fda.gov |
| December 4, 2014 | 69814 | Class II | Terminated | Trilogy Fiber Metal Acetabular Shell Size 54 mm OD The Trilogy Acetabular System is indicated for either cemented or uncemented use in skeletally mature individuals undergoing primary or revision surgery for rehabilitati | Zimmer received a single complaint wherein a Trilogy® Fiber Metal Multi-Hole Acetabular Shell would not attach to the inserter/impactor instrumentation. Subsequent investigation found the polar-hole threads to be present but non-conforming to specifications, in that the minor diameter was undersized. Investigation also indicates that the issue is isolated an | accessdata.fda.gov |
| November 21, 2014 | 69851 | Class II | Terminated | Bone Screw, self-tapping The Trilogy shells are available in three configurations; uni, multi, and cluster-holed. The multi and cluster-holed shells allow for the use of screws to provide additional fixation and security | Analysis of returned complaint devices, product in inventory, and device manufacturing records has identified tool marks isolated to one specific machining mill to be the cause of the fractures.. | accessdata.fda.gov |
| June 12, 2014 | 68547 | Class II | Terminated | Zimmer EDI PERIARTICULAR PLATING SYSTEM CANCELLOUS BONE SCREW, FULLY THREADED, HEX HEAD 4MM DIAMETER, 14 MM LENGTH, and EDI 4.0 MM CANCELLOUS SCREW, FULLY THREADED, 20 MM LENGTH. Temporary internal fixation devices, desi | Two lots of screws were commingled. Screws with etching and machining for lot number 62629432 were packaged in bags labeled for lot number 62628759; and screws with etching and machining for lot number 62628759 were packaged in bags labeled for lot number 62629432. The affected product was distributed between 3/6/14 and 4/21/14. | accessdata.fda.gov |
Compare with other makers
- All makers of Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
- All makers of Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer
- All makers of Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer
- All makers of Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
- All makers of Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
- All makers of Screw, Fixation, Bone
Updated December 10, 2021. 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.