Device product
Depuy Spine Side Fire Needles 11G X 4IN, part of the Confidence Spinal Cement System Product Code: 283904411. The Confidence Side Fire Needle is used to place bone cement in an intra-vertebral fashion at a desired location. the cement extrudes fro the needle through a port on the side of the needle.
Z-1938-2012
Product summary
- Event
- Event 61874
- Status
- Terminated
- Classification
- Class II
- Quantity
- 704 units
- Official record key
device-enforcement:Z-1938-2012
Official wording
Reason: Additional Instructions for Use and Surgical Technique for the Confidence Needle due to reports of breakage with the side fire needles
Code information: All lots
Distribution pattern: Worldwide Distribution-USA (nationwide) and the countries of Canada, Austria, China, Croatia, Czech Republic, France, Germany, Greece, Hungary, Italy, Lebanon, Netherlands, New Zealand, Poland, Russian Federation, Singapore, South Africa, Spain, Switzerland, Turkey, UAE, and UK.
Derived failure modes
-
Unknown
Additional Instructions for Use and Surgical Technique for the Confidence Needle due to reports of breakage with the side fire needles