Recall Z-0429-2014 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 29, 2013 (initiated Aug 1, 2013) |
| Status | Terminated |
| Reason | The small extendible Soft Tissue Retractor was recalled due to locking nut (clamping sleeve) malfunction. |
| Root cause | Use error |
| Action | Synthes sent an Field Safety Notification letter dated August 1, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were instructed to take the following actions: Exchange the old surgical technique guide with the new guide version F provided with this notification. Review the revised surgical technique guide. Forward this Field Safety Notification to anyone in your facility that needs to be informed. If the technique guide has been forwarded to another facility, contact that facility. Maintain awaren |
| Quantity | 374 |
| Distribution | Worldwide Distribution - USA (nationwide) and Internationally to Canada and Mexico. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.