FDA-Device2013-12-04Class II
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
Synthes USA HQ, Inc.
Hazard
Complaints were received which described the SynFix LR implant holder breaking at the interface between the implant and the holder.
Sold states
Worldwide Distribution - USA (nationwide) and Internationally to Canada .
Affected count
548
Manufactured in
1302 Wrights Ln E, N/A, West Chester, PA, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0405-2014Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief