Class II
Medical Device Recall: CUSTOM KNEE - 206061-Procedure Kit Catalog Number: UDKN68AG
American Contract Systems Inc · May 15, 2024
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.
Distribution
US Nationwide distribution.
States Affected
NATIONWIDE
Quantity Affected
174 units
Source: FDA (openFDA Device Enforcement)
Recall number: Z-2308-2024
Status: ongoing
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