Synthes Soft Tissue Retractor Small Extendible Offset blade facilitates easy preparation of the epipereosteal cavity for percutaneous plate insertion.
Recall
- Recall Number
- Z-0341-2014
- Event Number
- 66529
- Firm
- Synthes USA HQ, Inc.
- FEI Number
- 3005180112
- Product Code
- GAD
- Status
- Terminated
- Root Cause
- Device Design
- Initiated
- September 24, 2013
- Posted
- November 18, 2013
- Terminated
- June 1, 2015
- Address
- 1302 Wrights Ln E, West Chester, PA, 19380-3417
Description
Synthes Soft Tissue Retractor Small Extendible Offset blade facilitates easy preparation of the epipereosteal cavity for percutaneous plate insertion.
The potential exists for the locking screw nut to break on the Soft Tissue Retractor if it is overt-tightened.
Synthes sent an Urgent Notice: Medical Device Recall letter dated July 31, 2013. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to review their inventory and immediately remove the affected lots from stock, call Synthes at 1-800-479-6329 to obtain a Return Authorization Number. Complete the Verification Section at the letter by checking the appropriate box indicating affected product has been located and return the Verification Form with the product to Credit/Returns, Synthes, 1101 Synthes Avenue, Monument, CO 80132. If customers do not have the identified product, they were instructed to complete the Offset blade facilitates easy preparation of the epipereosteal cavity for percutaneous plate insertion.e attached Verification Section and return to Synthes.
Worldwide Distribution - USA (Nationwide) and Canada.
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