FDA-Device2024-07-17Class II
TOTAL KNEE - 302497- Procedure tray Catalog Number: ANTK12AF
American Contract Systems Inc
Hazard
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.
Sold states
US Nationwide distribution.
Affected count
66 units
Manufactured in
85 Shaffer Park Dr, N/A, Tiffin, OH, United States
Products
TOTAL KNEE - 302497- Procedure tray Catalog Number: ANTK12AF
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2275-2024Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief