Recall Z-0341-2014— Synthes USA HQ, Inc.
Class II · Terminated
Class II FDA medical device recall by Synthes USA HQ, Inc., initiated 2013-09-24, terminated 2015-06-01. 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 potential exists for the locking screw nut to break on the Soft Tissue Retractor if it is overt-tightened..
- Recalling firm
- Synthes USA HQ, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2013-09-24
- Terminated
- 2015-06-01
- 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 potential exists for the locking screw nut to break on the Soft Tissue Retractor if it is overt-tightened.
Data sourced from openFDA. This site is unofficial and independent of the FDA.