FDANovember 17, 2021device
DYNANAIL MINI, Endcap +6mm, REF 2600-05-006, Rx Only, Sterile
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
The firm identified a nonconformance in Lot 04882 involving the endcap being manufactured to a longer length than indicated in product specifications, introducing the risk of the +6 mm endcap not seating flush with the nail while inserting during a procedure.
What to do
FDA enforcement status: Ongoing
Brands named
medshape
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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