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U.S. Department of Health and Human Services

Class 2 Device Recall Depuy DELTA Xtend

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  Class 2 Device Recall Depuy DELTA Xtend see related information
Date Initiated by Firm July 10, 2008
Date Posted January 15, 2009
Recall Status1 Terminated 3 on October 28, 2009
Recall Number Z-0533-2009
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 Humerus PE Cup, Dia 38/+6 STD, sterile, Depuy France; REF 130738206.

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 2		 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 and Original Applicant = DEPUY ORTHOPAEDICS, INC.
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