Recall Z-0341-2014 ยท GAD Retractor
Synthes USA HQ, Inc.
Synthes Soft Tissue Retractor Small Extendible Offset blade facilitates easy preparation of the epipereosteal cavity for percutaneous plate insertion.
| Date | Nov 18, 2013 (initiated Sep 24, 2013) |
| Status | Terminated |
| Reason | The potential exists for the locking screw nut to break on the Soft Tissue Retractor if it is overt-tightened. |
| Root cause | Device Design |
| Action | 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. |
| Quantity | 374 |
| Distribution | Worldwide Distribution - USA (Nationwide) and Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.