FDAFDA · Food and drugs·Recall number Z-0405-2014
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
Published December 4, 2013 · Recall initiated: October 8, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Complaints were received which described the SynFix LR implant holder breaking at the interface between the implant and the holder.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Synthes USA HQ, Inc.
- Distributor
- Worldwide Distribution - USA (nationwide) and Internationally to Canada .
- Lot
- all lots of part no. 03.802.039
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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