The Recall Desk
HighFDA (Devices)·Z-2302-2024·Announced 2024-07-17

Medical knee procedure kit recalled for excessive sterilization chemical residue

American Contract Systems Inc is recalling TOTAL KNEE-Procedure Kits due to excessive ethylene oxide and ethylene chlorohydrin residues on the cast padding component. The recall affects 85 units distributed nationwide.

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 Class II recall. The hazard involves sterilization residue exceeding established safety limits on a permanent-exposure medical device, constituting a risk of chemical exposure. No illnesses or injuries are documented in the source. Per the rubric, this is High (Score 3): risk-of-harm products without reported injury.

Plain-English summary

American Contract Systems Inc is recalling TOTAL KNEE-Procedure Kits (Catalog Number SMTK21C) distributed nationwide. Testing revealed that ethylene oxide and ethylene chlorohydrin (EO/ECH) residuals on the cast padding component exceeded the safe residual limits established by ANSI/AAMI/ISO 10993-7:(R)2012 standards for permanent exposure medical devices.

The recall affects 85 units with the following lot numbers: 975241, 956241, 920241, and 907241. The UDI-DI for this product is 00191072203205. Products were distributed throughout the United States.

Facilities and healthcare providers who received affected units should stop using them immediately and contact American Contract Systems Inc for return and replacement instructions. FDA has classified this as a Class II recall.

The recalled product

Product
TOTAL KNEE-Procedure Kit Catalog Number: SMTK21C
Manufacturer
American Contract Systems Inc
Category
Medical Device — Orthopedic Surgical Kit
Hazard
  • ethylene-oxide-residue
  • sterilization-residue

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 (1)

  • UDI-DI: 00191072203205 LOT#"s: 975241 956241 920241 907241

Distribution

Distributed nationwide across the United States.

Related recalls

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