Knee Procedure Kit Recalled Due to Ethylene Oxide Residual Contamination
American Contract Systems Inc recalls 174 units of CUSTOM KNEE procedure kits due to ethylene oxide and ethylene chlorohydrin residuals exceeding safe exposure limits for permanent contact devices.
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 FDA Class II recall involves chemical residuals exceeding established safety limits for permanent tissue contact devices; however, no illnesses or injuries have been reported, placing it in the 'High' category as a potential risk-of-harm product without reported adverse outcomes.
Plain-English summary
American Contract Systems Inc is recalling 174 units of the CUSTOM KNEE - 206061-Procedure Kit (Catalog Number: UDKN68AG, Lot 955241) distributed nationwide. Testing identified that ethylene oxide and ethylene chlorohydrin residuals in the cast padding component exceeded the allowable limits specified in ANSI/AAMI/ISO 10993-7 standards for permanent exposure medical devices.
The product was distributed nationwide to healthcare facilities and providers. Affected units are identified by Lot 955241 (UDI-DI: 00191072216335). The chemical residuals on the cast padding component exceed the established safety thresholds for devices intended for permanent contact with tissue.
Healthcare providers and facilities with the affected lot should contact the manufacturer for return and replacement instructions. Persons who have undergone orthopedic procedures using this product should consult their healthcare provider if they have any concerns related to their treatment.
The recalled product
- Product
- CUSTOM KNEE - 206061-Procedure Kit Catalog Number: UDKN68AG
- Manufacturer
- American Contract Systems Inc
- Affected units
- 174
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: 00191072216335 LOT#"s: 955241
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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