Recall Z-0405-2014— Synthes USA HQ, Inc.
Class II · Terminated
Class II FDA medical device recall by Synthes USA HQ, Inc., initiated 2013-10-08, terminated 2016-08-26. FDA's recall record names no specific 510(k) clearance for this event. Product: Synthes Implant Holder for Synfix (TM)-LR the Synthes Implant Holder for Synfix (TM)-LR is a non-powered hand-held device intended for medical purposes to manipulate tissue, or for use with other devices in orthopedic surgery. Reason: Complaints were received which described the SynFix LR implant holder breaking at the interface between the implant and the holder..
- Recalling firm
- Synthes USA HQ, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2013-10-08
- Terminated
- 2016-08-26
- Firm location
- West Chester, PA, United States
Product description
Synthes Implant Holder for Synfix (TM)-LR the Synthes Implant Holder for Synfix (TM)-LR is a non-powered hand-held device intended for medical purposes to manipulate tissue, or for use with other devices in orthopedic surgery
Reason for recall
Complaints were received which described the SynFix LR implant holder breaking at the interface between the implant and the holder.
Data sourced from openFDA. This site is unofficial and independent of the FDA.