Knee Procedure Kit Recalled for Elevated Chemical Residuals
American Contract Systems Inc is recalling 26 TOTAL KNEE Procedure Kits due to excess ethylene oxide and ethylene chlorohydrin residues on the cast padding component that exceed safe exposure 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 an FDA Class II device recall involving ethylene oxide and ethylene chlorohydrin residues exceeding established safety limits for permanent implantable devices. The chemical residues present a potential exposure risk over the device's lifetime of use.
Plain-English summary
American Contract Systems Inc is recalling the TOTAL KNEE Procedure Kit (Catalog Number QPTK95B, Lot #911241). The recall involves 26 units distributed nationwide in the United States.
The kit's cast padding component contains elevated residual levels of ethylene oxide and ethylene chlorohydrin that exceed the safe exposure limits for permanent implantable devices according to industry standards ANSI/AAMI/ISO 10993-7:(R)2012.
Patients who received this device or healthcare providers with unused kits should contact American Contract Systems Inc to determine next steps regarding the recalled device.
The recalled product
- Product
- TOTAL KNEE -Procedure Kit Catalog Number: QPTK95B
- Manufacturer
- American Contract Systems Inc
- Affected units
- 26
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: 00191072221063 LOT#"s: 911241
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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