The Recall Desk
Severity pendingFDA (Devices)·Z-2472-2025·Announced 2025-09-03

AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) ANTERIOR HIP PACK, MOD

Pending LLM rewrite. Source: FDA_DEVICE Z-2472-2025.

Severity not yet assessed

We have not scored this recall against our rubric yet, so we are not showing a severity rating or our usual guidance. The agency’s own notice below is the authoritative source — read it first.

Plain-English summary

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.

The recalled product

Product
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 NUM
Manufacturer
American Contract Systems Inc
Category
Medical Device — Devices

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • 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

Distribution

Distributed in 2 states:

  • IL
  • LA

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