Prosthesis, Hip, Femoral, Resurfacing
Orthopedic · 21 CFR 888.3400
Recent MDR events
12,333 adverse event reports on file
- CONSERVE® FEMORAL RESURFACING HEAD 46MMJul 28, 2026InjuryMicroport Orthopedics Inc.3010536692-2026-00302
- CONSERVE® FEMORAL RESURFACING HEAD 42MMJul 28, 2026InjuryMicroport Orthopedics Inc.3010536692-2026-00298
- CONSERVE® FEMORAL RESURFACING HEAD 48MMJul 28, 2026InjuryMicroport Orthopedics Inc.3010536692-2026-00310
- CONSERVE® FEMORAL RESURFACING HEAD 44MMJul 28, 2026InjuryMicroport Orthopedics Inc.3010536692-2026-00366
- CONSERVE® FEMORAL RESURFACING HEAD 46MMJul 28, 2026InjuryMicroport Orthopedics Inc.3010536692-2026-00383
- RECAP PF FMRL HD RESURF 46MMJul 20, 2026InjuryZimmer Biomet, Inc.0001825034-2026-02142
- CONSERVE® CEMENTLESS FEMORAL COMPONENT 46MMJul 9, 2026InjuryMicroport Orthopedics Inc.3010536692-2026-00237
- CONSERVE® CEMENTLESS FEMORAL COMPONENT 46MMJun 30, 2026InjuryMicroport Orthopedics Inc.3010536692-2026-00235
- RECAP HIP SYSTEMJun 12, 2026InjuryZimmer Biomet, Inc.0001825034-2026-01735
- RECAP HIP SYSTEMJun 11, 2026InjuryZimmer Biomet, Inc.0001825034-2026-01712
Event type breakdown
Recalls
16 recall events for this product code
- Zimmer, Inc.TerminatedNov 6, 2012
Metasul Durom Femoral component
Zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Wintetthur, Switzerland, after receiving four complaints of a discrepancy between product patient labels and product labels with respect to the reference and lot numbers of the product. While the information printed on the product label is correct, the info
Z-0216-2013 · View FDA record ↗ - Depuy Orthopaedics, Inc.TerminatedMar 24, 2011
ASR FEMORAL IMPLANT SIZE 39, DEPUY ASR RESURFACING FEMORAL HEADS, DePuy Articular Surface Replacement (ASR) Hip Prosthesis System.
As part of our ongoing post-market surveillance of all products, DePuy is continually evaluating data from a variety of sources including national joint replacement registries, published literature, company sponsored clinical trials, internal complaints data and unpublished clinical research reports. DePuy Orthopaedics issued a Field Safety Notice in March 2010 after receiving new data from the
Z-1763-2011 · View FDA record ↗ - Depuy Orthopaedics, Inc.TerminatedMar 24, 2011
TOTAL ASR FEM IMP SIZE 41, DEPUY ASR RESURFACING FEMORAL HEADS, DePuy Articular Surface Replacement (ASR) Hip Prosthesis System.
As part of our ongoing post-market surveillance of all products, DePuy is continually evaluating data from a variety of sources including national joint replacement registries, published literature, company sponsored clinical trials, internal complaints data and unpublished clinical research reports. DePuy Orthopaedics issued a Field Safety Notice in March 2010 after receiving new data from the
Z-1764-2011 · View FDA record ↗ - Depuy Orthopaedics, Inc.TerminatedMar 24, 2011
TOTAL ASR FEM IMP SIZE 43, DEPUY ASR RESURFACING FEMORAL HEADS, DePuy Articular Surface Replacement (ASR) Hip Prosthesis System.
As part of our ongoing post-market surveillance of all products, DePuy is continually evaluating data from a variety of sources including national joint replacement registries, published literature, company sponsored clinical trials, internal complaints data and unpublished clinical research reports. DePuy Orthopaedics issued a Field Safety Notice in March 2010 after receiving new data from the
Z-1765-2011 · View FDA record ↗ - Depuy Orthopaedics, Inc.TerminatedMar 24, 2011
TOTAL ASR FEM IMP SIZE 45, DEPUY ASR RESURFACING FEMORAL HEADS, DePuy Articular Surface Replacement (ASR) Hip Prosthesis System.
As part of our ongoing post-market surveillance of all products, DePuy is continually evaluating data from a variety of sources including national joint replacement registries, published literature, company sponsored clinical trials, internal complaints data and unpublished clinical research reports. DePuy Orthopaedics issued a Field Safety Notice in March 2010 after receiving new data from the
Z-1766-2011 · View FDA record ↗ - Depuy Orthopaedics, Inc.TerminatedMar 24, 2011
ASR FEMORAL IMPLANT SIZE 47, DEPUY ASR RESURFACING FEMORAL HEADS, DePuy Articular Surface Replacement (ASR) Hip Prosthesis System.
As part of our ongoing post-market surveillance of all products, DePuy is continually evaluating data from a variety of sources including national joint replacement registries, published literature, company sponsored clinical trials, internal complaints data and unpublished clinical research reports. DePuy Orthopaedics issued a Field Safety Notice in March 2010 after receiving new data from the
Z-1767-2011 · View FDA record ↗ - Depuy Orthopaedics, Inc.TerminatedMar 24, 2011
ASR FEMORAL IMPLANT SIZE 49, DEPUY ASR RESURFACING FEMORAL HEADS, DePuy Articular Surface Replacement (ASR) Hip Prosthesis System.
As part of our ongoing post-market surveillance of all products, DePuy is continually evaluating data from a variety of sources including national joint replacement registries, published literature, company sponsored clinical trials, internal complaints data and unpublished clinical research reports. DePuy Orthopaedics issued a Field Safety Notice in March 2010 after receiving new data from the
Z-1768-2011 · View FDA record ↗ - Depuy Orthopaedics, Inc.TerminatedMar 24, 2011
ASR FEMORAL IMPLANT SIZE 51, DEPUY ASR RESURFACING FEMORAL HEADS, DePuy Articular Surface Replacement (ASR) Hip Prosthesis System.
As part of our ongoing post-market surveillance of all products, DePuy is continually evaluating data from a variety of sources including national joint replacement registries, published literature, company sponsored clinical trials, internal complaints data and unpublished clinical research reports. DePuy Orthopaedics issued a Field Safety Notice in March 2010 after receiving new data from the
Z-1769-2011 · View FDA record ↗ - Depuy Orthopaedics, Inc.TerminatedMar 24, 2011
ASR FEMORAL IMPLANT SIZE 53, DEPUY ASR RESURFACING FEMORAL HEADS, DePuy Articular Surface Replacement (ASR) Hip Prosthesis System.
As part of our ongoing post-market surveillance of all products, DePuy is continually evaluating data from a variety of sources including national joint replacement registries, published literature, company sponsored clinical trials, internal complaints data and unpublished clinical research reports. DePuy Orthopaedics issued a Field Safety Notice in March 2010 after receiving new data from the
Z-1770-2011 · View FDA record ↗ - Depuy Orthopaedics, Inc.TerminatedMar 24, 2011
ASR FEMORAL IMPLANT SIZE 55, DEPUY ASR RESURFACING FEMORAL HEADS, DePuy Articular Surface Replacement (ASR) Hip Prosthesis System.
As part of our ongoing post-market surveillance of all products, DePuy is continually evaluating data from a variety of sources including national joint replacement registries, published literature, company sponsored clinical trials, internal complaints data and unpublished clinical research reports. DePuy Orthopaedics issued a Field Safety Notice in March 2010 after receiving new data from the
Z-1771-2011 · View FDA record ↗
Registered firms
54 firms currently registered for this product code
Zimmer Biomet Korea Ltd.
Seoul, KR
Arthrosurface, Inc.
W Bridgewater, MA, US
Zimmer, Inc.
WARSAW, IN, US
Isomedix Operations, Inc.
Libertyville, IL, US
Biomet Chile S.a.
Santiago de Chile Region Metropolitana, CL
Isomedix Operations Inc.
Northborough, MA, US
Zimmer (shanghai) Medical International Trading Co., Ltd.
Shanghai, CN
Aps Materials, Inc.
DAYTON, OH, US
Zimmer Pte. Ltd.
Singapore South East, SG
Zimmer Gmbh
WINTERTHUR Zurich, CH
Symmetry Medical Manufacturing Inc
CLAYPOOL, IN, US
Biocore9 Llc
Denville, NJ, US
Isomedix Operations Inc.
SPARTANBURG, SC, US
Primo Medical Group, Inc
STOUGHTON, MA, US
Symmetry Medical Manufacturing Inc.
WARSAW, IN, US
Biopro, Inc.
PORT HURON, MI, US
Signature Orthopaedics Pty Limited
Sydney New South Wales, AU
Microport Orthopedics Inc.
Arlington, TN, US
510(k) clearances
23 clearances for this product code
- Biocore9, LLCJan 19, 2021
K201219 · Biocore9 Femoral Head Resurfacing Component
- Corin USAApr 15, 2010
K092198 · CORMET CEMENTLESS RESURFACING FEMORAL HEAD
- WrightmedicaltechnologyincDec 12, 2008
K082673 · CONSERVE PRESSFIT FEMORAL COMPONENT
- Biomet, Inc.Jun 29, 2007
K071053 · RECAP HA PRESS-FIT FEMORAL RESURFACING HEAD
- Zimmer GmbHApr 26, 2007
K070292 · DUROM HIP RESURFACING SYSTEM, FEMORAL COMPONENTS
- WrightmedicaltechnologyincDec 1, 2006
K062960 · CONSERVE FEMORAL RESURFACING COMPONENT
- Biopro, Inc.May 18, 2005
K043542 · BIOPRO TARA FEMORAL RESURFACING COMPONENT
- DePuy Orthopaedics, Inc.Dec 4, 2003
K032659 · DEPUY ASR RESURFACING FEMORAL HEADS