Device 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
Z-0405-2014
Product summary
- Event
- Event 66577
- Status
- Terminated
- Classification
- Class II
- Quantity
- 548
- Official record key
device-enforcement:Z-0405-2014
Official wording
Reason: Complaints were received which described the SynFix LR implant holder breaking at the interface between the implant and the holder.
Code information: all lots of part no. 03.802.039
Distribution pattern: Worldwide Distribution - USA (nationwide) and Internationally to Canada .
Derived failure modes
-
Unknown
Complaints were received which described the SynFix LR implant holder breaking at the interface between the implant and the holder.