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Synthes (USA) Products LLC recalls Hammertoe Continuous Compression Implant (CCI) Kit Part Number: 46.239.001
Recalled October 12, 2022 · FDA recall Z-0008-2023 · Synthes (USA) Products
Hazard
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 · FDA Class II
Units
191 units
Sold at
US Nationwide distribution.
Description
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
Product
Hammertoe Continuous Compression Implant (CCI) Kit Part Number: 46.239.001
Manufacturer(s)
Synthes (USA) Products LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →