DePuy CONFIDENCE SPINAL CEMENT SYSTEM 11C Plus KIT Catalog Number: 283910000. Delivery of CONFIDENCE Spinal Cement, whic
FDA device recall Z-0962-2013 · posted 2013-03-18 · Terminated
Recall details
- Recalling firm
- DePuy Spine, Inc.
- Reason for recall
- Cement mixer used to prepare cement for surgery may not turn properly and may jam or stuck
- Action taken
- DePuy Synthes Spine issued notification letter dated 1/11/13 issued via UPS Next Day Air Saver on 17 January 2013. Accounts requested to review inventory, quarantine any products listed in this recall notice and to complete and return the enclosed Business Reply Form. Contact the firm at 508-977-6606 for questions relating to this notice.
- Root cause
- Process control
- Status
- Terminated
- Product code
- NDN
- Quantity affected
- 7773
- Distribution
- Worldwide Distribution-USA (nationwide) and the countries of Argentina, Armenia, Kazakhstan, Russia, Ukraine, Australia, Austria Belgium, Luxembourg , Brazil, Canada, China, Colombia, Cyprus, Jordan L
- Date initiated
- 2013-01-15
- Date posted
- 2013-03-18
- Date terminated
- 2014-06-30
- Location
- Raynham, MA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| CONFIDENCE HIGH VISCOSITY BONE CEMENT (K060300) | Disc-O-Tech Medical Technologies, Ltd. | 2006-06-21 |