DePuy CONFIDENCE SPINAL CEMENT SYSTEM KIT Catalog Number: 283913000. Delivery of CONFIDENCE Spinal Cement, which is indicated for fixation of pathological fractures.
Reported: March 27, 2013 Initiated: January 15, 2013 #Z-0963-2013
Product Description
DePuy CONFIDENCE SPINAL CEMENT SYSTEM KIT Catalog Number: 283913000. Delivery of CONFIDENCE Spinal Cement, which is indicated for fixation of pathological fractures.
Reason for Recall
Cement mixer used to prepare cement for surgery may not turn properly and may jam or stuck
Details
- Recalling Firm
- DePuy Spine, Inc.
- Units Affected
- 6668
- 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, Poland, Portugal Singapore, Slovakia, Slovenia, South Africa, Spain, Switzerland, Turkey, and UK.
- Location
- Raynham, MA
Frequently Asked Questions
What product was recalled? ▼
DePuy CONFIDENCE SPINAL CEMENT SYSTEM KIT Catalog Number: 283913000. Delivery of CONFIDENCE Spinal Cement, which is indicated for fixation of pathological fractures.. Recalled by DePuy Spine, Inc.. Units affected: 6668.
Why was this product recalled? ▼
Cement mixer used to prepare cement for surgery may not turn properly and may jam or stuck
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on March 27, 2013. Severity: Moderate. Recall number: Z-0963-2013.
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