The Recall Desk
HighFDA (Devices)·Z-2278-2024·Announced 2024-07-17

Knee surgery procedure tray recalled for chemical contamination

American Contract Systems is recalling TOTAL KNEE procedure trays (Catalog Number BFTK01AA) due to ethylene oxide and ethylene chlorohydrin residuals in the cast padding component that exceed acceptable regulatory limits.

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: This is a Class II recall involving chemical residuals (ethylene oxide/ethylene chlorohydrin) that exceed regulatory limits for permanent exposure medical devices. Although no injuries have been reported, the elevated chemical residuals represent a potential risk of harm to patients and healthcare workers, fitting the rubric criterion for High severity.

Plain-English summary

American Contract Systems Inc. is recalling the TOTAL KNEE - 247546 Procedure tray (Catalog Number BFTK01AA), a surgical procedure tray used in knee surgery.

The cast padding component contains Ethylene Oxide and Ethylene Chlorohydrin (EO/ECH) residuals that exceed the allowable limits for permanent exposure medical devices according to the ANSI/AAMI/ISO 10993-7 standard. This Class II recall addresses non-compliant chemical residuals that exceed regulatory safe thresholds.

The affected procedure trays were distributed nationwide throughout the United States under Lot #922241 (UDI-DI: 00191072215970).

The recalled product

Product
TOTAL KNEE - 247546 - Procedure tray Catalog Number: BFTK01AA
Manufacturer
American Contract Systems Inc
Category
Medical Device — Orthopedic Surgery
Hazard
  • ethylene-oxide-residuals

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: 00191072215970 LOT#"s: 922241

Distribution

Distributed nationwide across the United States.

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