FDA-Device2024-07-17Class II
CUSTOM KNEE - 206061-Procedure Kit Catalog Number: UDKN68AG
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
174 units
Manufactured in
85 Shaffer Park Dr, N/A, Tiffin, OH, United States
Products
CUSTOM KNEE - 206061-Procedure Kit Catalog Number: UDKN68AG
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2308-2024Don't want to check this manually?
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