Recall Z-2307-2024— American Contract Systems Inc

Name: FDA recall Z-2307-2024
Creator: U.S. Food and Drug Administration
Published: 2024-05-15

Class II · Ongoing

Class II FDA medical device recall by American Contract Systems Inc, initiated 2024-05-15. FDA's recall record names no specific 510(k) clearance for this event. Product: CUSTOM KNEE - 206061-Procedure Kit Catalog Number: UDKN68AE. Reason: 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..

Recalling firm: American Contract Systems Inc
Classification: Class II
Status: Ongoing
Initiated: 2024-05-15
Firm location: Tiffin, OH, United States

Product description

CUSTOM KNEE - 206061-Procedure Kit Catalog Number: UDKN68AE

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.