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.
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: 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
- Affected units
- 85
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.
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.
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