Home / Recalls / Medical Devices
American Contract Systems Inc recalls KNEE SCOPE Procedure tray Catalog Number: COKN48L
Recalled July 17, 2024 · FDA recall Z-2287-2024 · 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
36 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
KNEE SCOPE Procedure tray Catalog Number: COKN48L
Manufacturer(s)
American Contract Systems Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →