Device product
Vilex, Inc., FUZE 10.0 mm x 250 mm, Product # FZ100-250T-25. Ankle arthrodesis, tibio-talo-calcaneal arthrodesis.
Z-1723-2015
Product summary
- Event
- Event 71344
- Status
- Terminated
- Classification
- Class II
- Quantity
- 4 units
- Official record key
device-enforcement:Z-1723-2015
Official wording
Reason: Incidence of breakage is higher than expected.
Code information: all codes
Distribution pattern: Distributed in the states of MS, MD, PA, and TX.
Derived failure modes
-
Unknown
Incidence of breakage is higher than expected.