| Class 2 Device Recall Depuy DELTA Xtend | |
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
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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
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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 |
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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.
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510(K) Database | 510(K)s with Product Code = KWS
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