FDA Medical Device Recalls (openFDA)
Depuy Orthopaedics, Inc.: DePuy ASR 300 Acetabular Implant, 56 mm, 999830756, sterile, DePuy International, Ltd, Leeds, United Kingdom.
- Recall number
- Z-2052-2010
- Recalling firm
- Depuy Orthopaedics, Inc.
- Product
- DePuy ASR 300 Acetabular Implant, 56 mm, 999830756, sterile, DePuy International, Ltd, Leeds, United Kingdom.
- Status
- Terminated
- Initiated
- 2010-03-05
- Posted
- 2010-07-17
- Terminated
- 2012-05-10
- Reason
- 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joint replacement registries, published literature, company sponsored clinical trials, internal complaints data and unpublished clinical research reports.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
- Root cause
- Other
- Action
- 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.
- Quantity
- 309
- Distribution
- Nationwide
- Lot, serial or model codes
- 2694163, 2694164, 2710382, 2710383, 2711351, 2711352, 2733790, 2733791, 2733792, 2738850, 2738851, 2745770, 2745771, 2745773, 2746486, 2746487, 2746488, 2767502, 2767503, 2773087, 2773088, 2774576, 2774577, 2774578, 2774579, 2796973, 2796974, 2815997, 2815998, 2821025, 2821026, 2833742, 2833743, 2842738, 2842739, 2858316, 2858317, 2863683 and 2890593.
- 510(k) numbers
- ["K040627","K073413","K080991"]
- PMA numbers
- not on file
- Product code
- KWA
- Firm FEI
- 1818910
- Firm city
- Warsaw
- Firm state
- IN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28