Class 2 Device Recall Depuy DELTA Xtend

• Date Initiated by Firm: July 10, 2008
• Date Posted: January 15, 2009
• Recall Status: Terminated on October 28, 2009
• Recall Number: Z-0539-2009
• Recall Event ID: 49112
• 510(K)Number: K062250 K081620
• Product Classification: Prosthesis, shoulder, semi-constrained, metal/polymer cemented - Product Code KWS
• Product: Depuy DELTA Xtend, Standard Humeral PE Cup, Dia 42+6R RET, sterile, Depuy France; REF 130742106. The device is used as a shoulder implant.
• Code Information: All lots.
• Recalling Firm/ Manufacturer: Depuy Orthopaedics, Inc.; 700 Orthopaedic Dr; Warsaw IN 46582-3994
• For Additional Information Contact: 800-473-3789
• Manufacturer Reason for Recall: Compressed air may become trapped between the cup and the stem, preventing the tapered walls from engaging and causing the cup to feel unstable.
• FDA Determined Cause: Device Design
• Action: A letter, "Urgent Device Correction" dated July 8, 2008 was sent via certified mail to implanting surgeons advising them of the issues and guidance on how to mitigate the problem. A communication was also sent to all sales representatives and territory offices on July 15, 2008. For questions, please contact Depuy Orthopaedics, Inc. Customer Service at 1-800-473-3789.
• Quantity in Commerce: 1,521 of all devices.
• Distribution: Nationwide Distribution.
• 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 = KWS