FDA recall Z-2275-2024

American Contract Systems Inc · Class II · device

Product

TOTAL KNEE - 302497- Procedure tray Catalog Number: ANTK12AF

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.

Key facts

Status: Ongoing
Initiation date: 2024-05-15
Report date: 2024-07-17
Voluntary/Mandated: Voluntary: Firm initiated
Location: Tiffin, OH, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2275-2024