Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

DePuy ASR 100 Acetabular Implant, 50 mm, 999800750, sterile, DePuy International, Ltd, Leeds, United Kingdom.

FDA Recall Z-203-2010 · Posted 2010-07-17

Recalling FirmDepuy Orthopaedics, Inc.
Recall StatusTerminated
Product CodeKWA
Date Initiated2010-03-05
Date Terminated2012-05-10
Product Quantity4987

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joint replacement registries, published literature, company sponsored clinical trials, internal complaints data and unpublished clinical research reports.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

Firm 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.

Root Cause

Other

Distribution Pattern

Nationwide

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K080991DEPUY ASR XL MODULAR ACETABULAR CUP SYSTEMDePuy Orthopaedics, Inc. · 2008-07-02K073413DEPUY ASR 300 ACETABULAR CUP SYSTEMDePuy Orthopaedics, Inc. · 2008-01-30K040627DEPUY ASR MODULAR ACETABULAR CUP SYSTEMDePuy Orthopaedics, Inc. · 2005-08-05

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑