Recall Z-2297-2024— American Contract Systems Inc
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: TOTAL KNEE - 297835 -Procedure Kit Catalog Number: RGTK10L. 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
TOTAL KNEE - 297835 -Procedure Kit Catalog Number: RGTK10L
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.