Device product
Synthes Soft Tissue Retractor Small Extendible. Offset blade facilitates easy preparation of the epipereosteal cavity for percutaneous plate insertion.
Z-0429-2014
Product summary
- Event
- Event 66530
- Status
- Terminated
- Classification
- Class II
- Quantity
- 374
- Official record key
device-enforcement:Z-0429-2014
Official wording
Reason: The small extendible Soft Tissue Retractor was recalled due to locking nut (clamping sleeve) malfunction.
Code information: Part J5957AC (old), and Part J5957F (new)
Distribution pattern: Worldwide Distribution - USA (nationwide) and Internationally to Canada and Mexico.
Derived failure modes
-
Unknown
The small extendible Soft Tissue Retractor was recalled due to locking nut (clamping sleeve) malfunction.