American Contract Systems Inc recalls ARTHO KNEE BAPTIST SOUTH PACK Procedure tray Catalog Number: BPKA49B

Recalled July 17, 2024 · FDA recall Z-2282-2024 · 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

129 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

ARTHO KNEE BAPTIST SOUTH PACK Procedure tray Catalog Number: BPKA49B

Manufacturer(s)

American Contract Systems Inc

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →