Recall Z-0429-2014— Synthes USA HQ, Inc.
Class II · Terminated
Class II FDA medical device recall by Synthes USA HQ, Inc., initiated 2013-08-01, terminated 2015-04-16. FDA's recall record names no specific 510(k) clearance for this event. Product: Synthes Soft Tissue Retractor Small Extendible. Offset blade facilitates easy preparation of the epipereosteal cavity for percutaneous plate insertion.. Reason: The small extendible Soft Tissue Retractor was recalled due to locking nut (clamping sleeve) malfunction..
- Recalling firm
- Synthes USA HQ, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2013-08-01
- Terminated
- 2015-04-16
- Firm location
- West Chester, PA, United States
Product description
Synthes Soft Tissue Retractor Small Extendible. Offset blade facilitates easy preparation of the epipereosteal cavity for percutaneous plate insertion.
Reason for recall
The small extendible Soft Tissue Retractor was recalled due to locking nut (clamping sleeve) malfunction.
Data sourced from openFDA. This site is unofficial and independent of the FDA.