FDADecember 16, 2019device
Stratum Lapidus Plate - Small Rt, Part No. STRM-LAP-SMR, UDI 00817701025467. The product is part of the Stratum Foot Plating System, a plate and screws construction indicated for bone fixation.
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
The product contains a different plate than indicated by the package labeling. The product is labeled as a right plate but contains a left plate.
What to do
FDA enforcement status: Terminated
Brands named
nextremity solutionsnextremity
UPCs
00817701025467
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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