American Contract Systems Inc recalls TPK ANTERIOR HIP PACK 176483-Procedure Kit Catalog Number: TPAH21E

Recalled July 17, 2024 · FDA recall Z-2305-2024 · American Contract Systems

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. · FDA Class II

Units

393 units

Sold at

US Nationwide distribution.

Description

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.

Product

TPK ANTERIOR HIP PACK 176483-Procedure Kit Catalog Number: TPAH21E

Manufacturer(s)

American Contract Systems Inc

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →