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American Contract Systems Inc recalls TOTAL KNEE, ST LUKES Catalog Number: LMTK17AP
Recalled July 17, 2024 · FDA recall Z-2290-2024 · American Contract Systems
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. · FDA Class II
Units
272 units
Sold at
US Nationwide distribution.
Description
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.
Product
TOTAL KNEE, ST LUKES Catalog Number: LMTK17AP
Manufacturer(s)
American Contract Systems Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →