Class II

Medical Device Recall: TOTAL KNEE - 297835 -Procedure Kit Catalog Number: RGTK10L

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

24 units

Source: FDA (openFDA Device Enforcement)

Recall number: Z-2297-2024

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.