openFDA Device Enforcement
Report-date coverage
June 20, 2012–July 08, 2026
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event_date_initiated coverage
June 01, 1997–June 30, 2026
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Hammertoe Continuous Compression Implant (CCI) Kit Part Number: 46.239.001
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