Device product
Spinal Rod Cutter, Item number 00392500200. The product is a nonsterile pin cutter - Product Usage: The intended use of this instrument is to be used for cutting orthopedic rods/pins during orthopedic surgeries.
Z-0696-2021
Product summary
- Event
- Event 86869
- Status
- Terminated
- Classification
- Class II
- Quantity
- 4713
- Official record key
device-enforcement:Z-0696-2021
Official wording
Reason: Device has the potential for fracture during use.
Code information: All lots
Distribution pattern: Domestic distribution nationwide. Foreign distribution to Australia, China, Hong Kong, India, Japan, Korea, New Zealand, Taiwan, Singapore, Thailand, Canada, Netherlands, Argentina, Brazil, Mexico, Venezuela, Panama, and Chile.
Derived failure modes
-
Unknown
Device has the potential for fracture during use.