High FDA (Devices)·Z-2472-2025·Announced 2025-09-03

Hip and knee procedure packs recalled over unconfirmed sterilization assurance requirements

American Contract Systems anterior hip, total knee and hip prosthesis packs are recalled because the firm cannot confirm that product sterilization assurance requirements were met. 588 units are affected.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: Rubric level 3 covers risk-of-harm products where injury has not yet been reported; unconfirmed sterility on an orthopaedic procedure pack is a potential harm and no injuries are reported.

Plain-English summary

American Contract Systems medical procedure kits and trays labelled as Anterior Hip Pack, model/item number AMAH40N; Total Knee Dan Myer, model/item number CCKM67F; Hip Prothesis Pack, model/item number HSTH03N; and DTC Anterior Hip Pack are being recalled. Affected kit lot numbers are listed in the recall notice, with UDI/DI 00191072235473 for the anterior hip pack. The recall covers 588 units distributed in Illinois and Louisiana.

During an internal investigation, American Contract Systems determined that the rationale for sterilization of certain components was not justified and that some components are not fit for further sterilization according to its procedures. As a result, the firm is unable to confirm that product sterilization assurance requirements were met. The FDA classified the action as Class II.

Hospitals and surgical centres holding these lot numbers should quarantine affected stock and follow the manufacturer's instructions for return or replacement.

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 — Procedure Kits
Hazard: sterility-assurance
surgical-kit
class-ii
Affected units: 588

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:

Part of a larger recall action

This product is one of 9 recalled by American Contract Systems Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 9 products in this recall →

Same manufacturer · American Contract Systems Inc

See all →

Moderate
American Contract Systems Recalls Convenience Kits with Non-Conforming Catheters
FDA (Devices) · 2026-09-02
Moderate
American Contract System Convenience Kit Recalled for Performance Failures
FDA (Devices) · 2026-09-02
Moderate
American Contract System Convenience Kit Recalled for Performance Failures
FDA (Devices) · 2026-09-02
Moderate
American Contract System Convenience Kits Recalled for Performance Failures
FDA (Devices) · 2026-09-02
High
Medicom Recalls Neurological Sponges Due to Endotoxin Variability
FDA (Devices) · 2026-08-26

Same hazard · sterility assurance