High FDA (Devices)·Z-0833-2024·Announced 2024-02-07

Orthopedic surgical kits recalled for unassessed external component sterilization

American Contract Systems recalls 5,524 orthopedic surgical kits due to unassessed sterilization of external components that may lose functionality, drug efficacy, or have excess sterilization chemical residue.

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: FDA classified this as Class II. The piggybacked components may lose functionality or drug efficacy due to unassessed sterilization exposure. While no illnesses or injuries have been reported, loss of functionality in surgical instruments used during procedures poses inherent risk of patient harm, meeting the rubric criterion for risk-of-harm products without confirmed injury.

Plain-English summary

American Contract Systems, Inc. is recalling 5,524 custom orthopedic surgical kits and trays distributed nationwide. During an internal investigation, the company identified that certain components from external suppliers were attached ('piggybacked') to ACS trays and subjected to the ACS sterilization process. No documentation existed confirming these external components were assessed to determine if they could safely withstand the elevated temperatures and extended sterilization exposure.

As a result, the piggybacked components may experience loss or lack of functionality, loss of drug efficacy (where applicable), and/or higher than specified ethylene oxide (EO) residuals. These kits are used in orthopedic surgical procedures including hip and knee replacement, shoulder arthroscopy, and extremity surgeries.

The affected kits comprise 51 different kit types, each identified by kit number and specific lot numbers with expiration dates. Customers should review the complete list of kit numbers and lot numbers from the FDA recall notice to determine if they have received affected products.

The recalled product

Product: Custom procedural convenience kits and trays, Othopedic use, labeled as: a) HIP FRACTURE, kit number AHHF15C; b) HIP FRACTURE, kit number AHHF15D; c) Hand Pack, kit number BBHP10E; d) Lower Extremity, kit number BBLE40B; e) Custom Podiatry, kit number BOCP70J; f) ROB
Manufacturer: American Contract Systems, Inc.
Category: Medical Device — Orthopedic Surgical Kits
Hazard: loss-of-functionality
loss-of-drug-efficacy
eo-residue
Affected units: 5,524

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)

a) AHHF15C
UDI/DI 00191072137524
Lot numbers: 696221
exp. 9/7/2023
741221
exp. 9/16/2023
787221
exp. 8/1/2023
873221
exp. 5/7/2023
b) AHHF15D
UDI/DI 00191072183552
Lot numbers: 890231
exp. 4/21/2024
959231
exp. 2/10/2024
652221
exp. 9/5/2023
c) BBHP10E
UDI/DI none

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 18 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 18 products in this recall →

Same manufacturer · American Contract Systems, Inc.

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