Total Knee Procedure Kit Recalled for Excess Sterilization Residuals
American Contract Systems Inc recalls the TOTAL KNEE Procedure Kit due to Ethylene Oxide and Ethylene Chlorohydrin residuals exceeding regulatory limits. No illnesses reported.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II recall with no reported illnesses or injuries. The hazard is theoretical and the recall is precautionary in nature.
Plain-English summary
American Contract Systems Inc is recalling the TOTAL KNEE Procedure Kit (Catalog Number QPTK95A, Lot Numbers 968241 and 922241). The product was distributed nationwide with 50 units affected.
The cast padding component contains Ethylene Oxide and Ethylene Chlorohydrin (EO/ECH) residuals from sterilization that exceed the limits specified in ANSI/AAMI/ISO 10993-7:(R)2012 for permanent exposure devices.
Healthcare facilities and healthcare providers who received this product should check their inventory against the affected lot numbers. If the product has been used or implanted, contact American Contract Systems Inc or the FDA. No illnesses or injuries have been reported in connection with this recall.
The recalled product
- Product
- TOTAL KNEE -Procedure Kit Catalog Number: QPTK95A
- Manufacturer
- American Contract Systems Inc
- Affected units
- 50
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: 00191072201225 LOT#"s: 968241 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.
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