TOTAL KNEE-Procedure Kit Recalled Due to Ethylene Oxide Residuals
American Contract Systems is recalling 976 units of TOTAL KNEE-Procedure Kits nationwide due to ethylene oxide and ethylene chlorohydrin residuals in the cast padding component that exceed safe exposure limits for medical devices.
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: FDA Class II recall involving chemical residuals exceeding safe exposure limits on a device with direct patient contact. This qualifies as a risk-of-harm product; per the rubric, such products without reported injuries score as High (3).
Plain-English summary
The TOTAL KNEE-Procedure Kit (Catalog Number SFTK54B) is being recalled nationwide by American Contract Systems Inc due to ethylene oxide and ethylene chlorohydrin residuals in the cast padding component that exceed the maximum allowable limits for permanent-exposure medical devices.
The cast padding will have direct contact with skin and body tissue during knee surgical procedures. The recalled kits (976 units) have lot numbers 680231, 997241, 969241, and 947241. Ethylene oxide and ethylene chlorohydrin are sterilization chemicals; when residuals exceed safe limits, they may cause adverse health effects.
Patients and healthcare providers who have these kits should contact American Contract Systems Inc for instructions on replacement or return. The company is working with the FDA to ensure affected units are removed from circulation.
The recalled product
- Product
- TOTAL KNEE-Procedure Kit Catalog Number: SFTK54B
- Manufacturer
- American Contract Systems Inc
- Hazard
- ethylene-oxide-residue
- ethylene-chlorohydrin-residue
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: 00191072195999 LOT#"s: 680231 997241 969241 947241
Distribution
Distributed nationwide across the United States.
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