FDAAugust 30, 2022device

Hammertoe Continuous Compression Implant (CCI) Kit Part Number: 46.239.001

Official recall recorded by the U.S. Food & Drug Administration.

The 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

What to do

FDA enforcement status: Ongoing

Brands named

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UPCs

00810633022047

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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