Device product
DePuy CONFIDENCE SPINAL CEMENT SYSTEM 5CC KIT Catalog Number:283905000. Delivery of CONFIDENCE Spinal Cement, which is indicated for fixation of pathological fractures.
Z-0960-2013
Product summary
- Event
- Event 64072
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1023
- Official record key
device-enforcement:Z-0960-2013
Official wording
Reason: Cement mixer used to prepare cement for surgery may not turn properly and may jam or stuck
Code information: All lots
Distribution pattern: 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, Poland, Portugal Singapore, Slovakia, Slovenia, South Africa, Spain, Switzerland, Turkey, and UK.
Derived failure modes
-
Unknown
Cement mixer used to prepare cement for surgery may not turn properly and may jam or stuck