CUSTOM KNEE Medical Device Procedure Kit recalled for excess chemical residuals
American Contract Systems Inc is recalling 174 units of the CUSTOM KNEE - 206061-Procedure Kit due to ethylene oxide and ethylene chlorohydrin residuals in the cast padding component. The residuals exceed the safety limits specified in ANSI/AAMI/ISO 10993-7:(R)2012 for permanent-contact 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: This is an FDA Class II recall involving chemical residuals that exceed biocompatibility standards for permanent-contact medical devices. While no injuries have been reported, the nature of the contamination represents a risk-of-harm situation.
Plain-English summary
The CUSTOM KNEE - 206061-Procedure Kit (Catalog Number UDKN68AE), manufactured by American Contract Systems Inc, is being recalled due to elevated levels of ethylene oxide and ethylene chlorohydrin (EO/ECH) residuals detected in the cast padding component. These residuals exceed the safety limits established by ANSI/AAMI/ISO 10993-7:(R)2012 for medical devices intended for permanent contact with human skin.
The recalled product was distributed nationwide in the United States. The recall affects 174 units identified with Lot number 651231 (UDI-DI: 00191072172532).
The presence of chemical residuals above regulatory biocompatibility limits creates a potential health risk for patients who receive treatment with the recalled device. The FDA classified this as a Class II recall.
Patients with this device or healthcare providers administering this product should contact American Contract Systems Inc for information about replacement units or if any adverse effects are experienced.
The recalled product
- Product
- CUSTOM KNEE - 206061-Procedure Kit Catalog Number: UDKN68AE
- Manufacturer
- American Contract Systems Inc
- Hazard
- ethylene-oxide-residual
- ethylene-chlorohydrin-residual
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: 00191072172532 LOT#"s: 651231
Distribution
Distributed nationwide across the United States.
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