Z-0008-2023 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- October 12, 2022
- Initiation Date
- August 30, 2022
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 191 units
Product Description
Hammertoe Continuous Compression Implant (CCI) Kit Part Number: 46.239.001
Reason for Recall
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
Distribution Pattern
US Nationwide distribution.
Code Information
UDI-DI: 00810633022047 Lot Numbers: MHC220119, MHC220120 Expiry Date: 1 June 2027