Device product
DePuy Synthes Hammertoe Continuous Compression Implants, Product No. 46.239.001
Z-0101-2023
Product summary
- Event
- Event 90918
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 196
- Official record key
device-enforcement:Z-0101-2023
Official wording
Reason: The subject products are being recalled because they contain the incorrect size drill guide and will not prepare the bone correctly for the size of the implant included in the sterile kit. If the incorrect drill guide is used, there is potential for bone damage due to incorrectly placed drill holes for the implant included in the kit.
Code information: UDI-DI (GTIN): 00810633022047 Lot/Expiry MHC200114 2/9/2026 MHC220117 3/2/2027
Distribution pattern: US Nationwide distribution.
Derived failure modes
-
Unknown
The subject products are being recalled because they contain the incorrect size drill guide and will not prepare the bone correctly for the size of the implant included in the sterile kit. If the incorrect drill guide is used, there is potential for bone damage due to incorrectly placed drill holes for the implant included in the kit.