AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) ANTERIOR HIP PACK, ...
FDA Recall #Z-2472-2025 — Class II — July 14, 2025
Product Description
AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) ANTERIOR HIP PACK, MODEL/ITEM NUMBER AMAH40N; 2)TOTAL KNEE DAN MYER, MODEL/ITEM NUMBER CCKM67F; 3)HIP PROTHESIS PACK, MODEL/ITEM NUMBER HSTH03N; 4)DTC ANTERIOR HIP PACK (PS 209459), MODEL/ITEM NUMBER MIAH65B; 5)DR WHIDD0N TOTAL HIP CPP, MODEL/ITEM NUMBER MPWH01B; 6)KNEE ARTHROSCOPY, MODEL/ITEM NUMBER SPKA57T; 7)ANTERIOR HIP PACK, MODEL/ITEM NUMBER WVAH40H.
Reason for Recall
During an internal investigation, ACS determined that the rationale for sterilization of certain components was not justified and therefore, some components are not fit for further sterilization according to ACS procedures. As a result, ACS is unable to confirm product sterilization assurance requirements were met.
Recalling Firm
American Contract Systems Inc — Tiffin, OH
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
588 units
Distribution
US distribution to states of: IL and LA
Code Information
1) MODEL/ITEM NUMBER AMAH40N: UDI/DI 00191072235473, Kit Lot Numbers: 42-7886011, 42-7990911; 2)MODEL/ITEM NUMBER CCKM67F: UDI/DI 00191072233578, Kit Lot Numbers: 70-053862, 70-053457, 70-053042, 70-052715, 70-052358, 70-051850, 70-051243; 3)MODEL/ITEM NUMBER HSTH03N: UDI/DI 00191072189615, Kit Lot Numbers: 42-7115711; 4)MODEL/ITEM NUMBER MIAH65B: UDI/DI 00191072235411, Kit Lot Numbers: 42-8134311; 5)MODEL/ITEM NUMBER MPWH01B: UDI/DI 00191072233271, Kit Lot Numbers: 5436801; 6)MODEL/ITEM NUMBER SPKA57T: UDI/DI 00191072235848, Kit Lot Numbers: 12-7400011, 12-7381311, 12-7358211, 12-7082111, 12-7157111, 12-7309911; 7)MODEL/ITEM NUMBER WVAH40H: UDI/DI 00191072233004, Kit Lot Numbers: 42-7897411, 42-7966211.
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated