DePuy ASR 300 Acetabular Implant, 66 mm, 999830766, sterile, DePuy International, Ltd, Leeds, United Kingdom.
FDA device recall Z-2057-2010 · posted 2010-07-17 · Terminated
Recall details
- Recalling firm
- Depuy Orthopaedics, Inc.
- Reason for recall
- Notification to clinicians of new revision rate data/information regarding the use of the device. As part of the post-market surveillance, 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joint replacement registries, published literature, company sponsored clinical trials, internal complaints data and unpublished clinical research reports. As part of the post-m
- Action taken
- DePuy Orthopaedics issued a Field Safety Notice to share the new data with surgeons and to reiterate the importance of correct implant positioning and patient selection in achieving optimal implant performance and survivorshop. For additional information regarding this matter, please contact the DePuy Scientific Information Office at 888 554 2482.
- Root cause
- Other
- Status
- Terminated
- Product code
- KWA
- Quantity affected
- 12
- Distribution
- Nationwide
- Date initiated
- 2010-03-05
- Date posted
- 2010-07-17
- Date terminated
- 2012-05-10
- Location
- Warsaw, IN
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| DEPUY ASR XL MODULAR ACETABULAR CUP SYSTEM (K080991) | DePuy Orthopaedics, Inc. | 2008-07-02 |
| DEPUY ASR 300 ACETABULAR CUP SYSTEM (K073413) | DePuy Orthopaedics, Inc. | 2008-01-30 |
| DEPUY ASR MODULAR ACETABULAR CUP SYSTEM (K040627) | DePuy Orthopaedics, Inc. | 2005-08-05 |