FDAFDA · Food and drugs·Recall number Z-2472-2025
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.
Published September 3, 2025 · Recall initiated: July 14, 2025
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- American Contract Systems Inc
- Distributor
- US distribution to states of: IL and LA
- Lot
- 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.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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