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FDAMarch 9, 2015device

DUAFIT(R) PIP 0o CA SIZE 3, REF A60 SP003, STERILE R, Rx only. Interphalangeal implant.

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

The hazard

Dimensional non-conformity leading to the impossibility to introduce the implant in the dedicated holder.

What to do

FDA enforcement status: Terminated

Brands named

in2bones sasin2bonesin2bones sas

Recall history

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

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