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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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
- Hazard
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.
Part of a larger recall action
This product is one of 39 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 39 products in this recall →Related recalls
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