Class 2 Device Recall DePuy ASR 300 Acetabular Implant, 56 mm

• Date Initiated by Firm: March 05, 2010
• Date Posted: July 17, 2010
• Recall Status: Terminated on May 10, 2012
• Recall Number: Z-2052-2010
• Recall Event ID: 55575
• 510(K)Number: K040627 K073413 K080991
• Product Classification: Prosthesis, hip, semi-constrained (metal uncemented acetabular component) - Product Code KWA
• Product: DePuy ASR 300 Acetabular Implant, 56 mm, 999830756, sterile, DePuy International, Ltd, Leeds, United Kingdom.
• Code Information: 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.
• Recalling Firm/ Manufacturer: Depuy Orthopaedics, Inc.; 700 Orthopaedic Dr; Warsaw IN 46582-3994
• For Additional Information Contact: 574-267-8143
• Manufacturer 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joint replacement registries, published literature, company sponsored clinical trials, internal complaints data and unpublished clinical research reports.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 Determined 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: 309
• Distribution: Nationwide
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = KWA