Orthopedic knee procedure tray recalled for sterilization residue levels
American Contract Systems Inc is recalling 84 units of the ARTHRO KNEE BEACHES PACK BHS procedure tray because residual sterilization chemicals exceeded permissible exposure limits. The affected units were distributed nationwide.
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 medical device recall involving chemical residue that exceeded regulatory sterilization limits. No reported illnesses or injuries; the hazard is a risk-of-harm situation where permissible exposure levels were breached rather than documented patient harm.
Plain-English summary
American Contract Systems Inc is recalling 84 units of the ARTHRO KNEE BEACHES PACK BHS procedure tray (Catalog Number BPKB46B) due to excessive residual levels of ethylene oxide and ethylene chlorohydrin (EO/ECH) in the cast padding component.
The residual sterilization chemical levels exceeded the permissible exposure limits for permanent-use medical devices as specified in the ANSI/AAMI/ISO 10993-7/(R)2012 standard.
The recalled units were distributed nationwide. The affected lot numbers are 992241 and 914241. Healthcare facilities and professionals with these units should contact American Contract Systems Inc for recall instructions.
No illnesses or injuries have been reported to date in connection with this recall.
The recalled product
- Product
- ARTHRO KNEE BEACHES PACK BHS- Procedure tray Catalog Number: BPKB46B
- Manufacturer
- American Contract Systems Inc
- Hazard
- ethylene-oxide-residue
- chemical-exposure
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: 00191072197948 LOT#"s: 992241 914241
Distribution
Distributed nationwide across the United States.
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