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Synthes USA HQ, Inc. recalls Synthes Implant Holder for Synfix (TM)-LR the Synthes Implant Holder for Synfix (TM)-LR is a non-powered hand-held de
Recalled December 4, 2013 · FDA recall Z-0405-2014 · Synthes USA HQ
Hazard
Complaints were received which described the SynFix LR implant holder breaking at the interface between the implant and the holder. · FDA Class II
Units
548
Sold at
Worldwide Distribution - USA (nationwide) and Internationally to Canada .
Description
Complaints were received which described the SynFix LR implant holder breaking at the interface between the implant and the holder.
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
Manufacturer(s)
Synthes USA HQ, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →