Depuy DELTA Xtend, Standard Humerus PE Cup, Dia 38/+6 STD, sterile, Depuy France; REF 130738206. The device is used as a
FDA device recall Z-0533-2009 · posted 2009-01-15 · Terminated
Recall details
- Recalling firm
- Depuy Orthopaedics, Inc.
- 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.
- Action taken
- 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.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- KWS
- Quantity affected
- 1,521 of all devices.
- Distribution
- Nationwide Distribution.
- Date initiated
- 2008-07-10
- Date posted
- 2009-01-15
- Date terminated
- 2009-10-28
- Location
- Warsaw, IN
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MODIFICATION TO DEPUY DELTA XTEND REVERSE SHOULDER SYSTEM (K081620) | DePuy Orthopaedics, Inc. | 2008-06-30 |
| DELTA XTEND REVERSE SHOULDER SYSTEM (K062250) | DePuy Orthopaedics, Inc. | 2007-02-02 |