Recall Z-0962-2013
DePuy Spine, Inc. · initiated January 15, 2013
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
DePuy CONFIDENCE SPINAL CEMENT SYSTEM 11C Plus KIT Catalog Number: 283910000. Delivery of CONFIDENCE Spinal Cement, which is indicated for fixation of pathological fractures.
Codes / lots: All lots
Reason for recall
Cement mixer used to prepare cement for surgery may not turn properly and may jam or stuck
FDA-determined cause: Process control
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.
Details
- Recall number
- Z-0962-2013
- Initiated
- January 15, 2013
- Posted by FDA
- March 18, 2013
- Terminated
- June 30, 2014
- Product code
- NDN – Cement, Bone, Vertebroplasty
- Quantity
- 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 Lebanon, Saudi Arabia, UAE, Czech Republic, Finland ,France, Germany, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Latvia, Malaysia Mexico, Netherlands, New Zealand, Norway, Sweden…
- Recalling firm
- DePuy Spine, Inc., Raynham, MA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0960-2013 Class II | DePuy CONFIDENCE SPINAL CEMENT SYSTEM 5CC KIT Catalog Number:283905000. Delivery of…Cement mixer used to prepare cement for surgery may not turn properly and may jam or stuck | 01/15/2013Terminated |
| Z-0961-2013 Class II | DePuy CONFIDENCE SPINAL CEMENT SYSTEM 7CC KIT Catalog Number: 283907000. Delivery of…Cement mixer used to prepare cement for surgery may not turn properly and may jam or stuck | 01/15/2013Terminated |
| Z-0963-2013 Class II | DePuy CONFIDENCE SPINAL CEMENT SYSTEM KIT Catalog Number: 283913000. Delivery of…Cement mixer used to prepare cement for surgery may not turn properly and may jam or stuck | 01/15/2013Terminated |