Z-2053-2010

DePuy ASR 300 Acetabular Implant, 58 mm, 999830758, sterile, DePuy International, Ltd, Leeds, United Kingdom

Name: Z-2053-2010 DePuy ASR 300 Acetabular Implant, 58 mm, 999830758, sterile, DePuy International, Ltd, Leeds, United Kingdom
Creator: Depuy Orthopaedics, Inc.
Published: 2010-03-05
License: https://open.fda.gov/license/

Depuy Orthopaedics Inc. / initiated 2010-03-05 / Terminated

FDA source

Depuy Orthopaedics, Inc. began a recall of DePuy ASR 300 Acetabular Implant, 58 mm, 999830758, sterile, DePuy International, Ltd, Leeds, United Kingdom on 2010-03-05. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2053-2010
Status: Terminated
Initiated: 2010-03-05
Posted: 2010-07-17
Terminated: 2012-05-10
Recalling firm: Depuy Orthopaedics Inc.
Product: DePuy ASR 300 Acetabular Implant, 58 mm, 999830758, sterile, DePuy International, Ltd, Leeds, United Kingdom.
Product code: KWA Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component)
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joint replacement registries, published literature, company sponsored clinical trials, internal complaints data and unpublished clinical research reports.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
FDA 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 in commerce: 225
Distribution: Nationwide
Product codes and lots: 2694165, 2694166, 2710387, 2710388, 2711353, 2711354, 2737075, 2737076, 2737077, 2737078, 2740036, 2740037, 2740038, 2740039, 2753164, 2753165, 2768761, 2768762, 2770748, 2770749, 2773911, 2773912, 2782374, 2782375, 2789029, 2789030, 2817024, 2817025 and 2834720.

Product code KWA

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)