Recall Z-0539-2009 ยท KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
Depuy Orthopaedics, Inc.
Depuy DELTA Xtend, Standard Humeral PE Cup, Dia 42+6R RET, sterile, Depuy France; REF 130742106. The device is used as a shoulder implant.
| Date | Jan 15, 2009 (initiated Jul 10, 2008) |
| Status | Terminated |
| Reason | Compressed air may become trapped between the cup and the stem, preventing the tapered walls from engaging and causing the cup to feel unstable. |
| Root 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 | 1,521 of all devices. |
| Distribution | Nationwide Distribution. |
| FDA record | Open on fda.gov |