Class II
Medical Device Recall: KNEE ARTHROSCOPY PACK Catalog Number: MEKA12R
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
84 units
Source: FDA (openFDA Device Enforcement)
Recall number: Z-2291-2024
Status: ongoing
SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.