Device product
Hammertoe Continuous Compression Implant (CCI) Kit Part Number: 46.239.001
Z-0008-2023
Product summary
- Event
- Event 90842
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 191 units
- Official record key
device-enforcement:Z-0008-2023
Official wording
Reason: Drill Pin (drill bit) is not compatible with the Drill Template included in the kit due to a packaging error, result in a surgical delay and may cause soft tissue damage if a larger incision is required to accommodate an alternative form of fixation. Additionally, there is a potential for adverse tissue reaction if the surgeon attempts to use the guide regardless of tight fit and plastic debris is created and ends up in the wound
Code information: UDI-DI: 00810633022047 Lot Numbers: MHC220119, MHC220120 Expiry Date: 1 June 2027
Distribution pattern: US Nationwide distribution.
Derived failure modes
-
Labeling or packaging
packaging error