FDAMay 15, 2024device

TOTAL KNEE, ST LUKES Catalog Number: LMTK17AP

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

The hazard

Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded the residual limits for permanent exposure devices as indicated by ANSI/AAMI/ISO 10993-7/(R)2012.

What to do

FDA enforcement status: Ongoing

Brands named

american contract systemsamericanamerican contract

UPCs

00191072192172

Recall history

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

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