Oxford Partial Knee System Recalled for Compromised Sterile Barrier
Biomet is recalling 7 units of the Oxford Partial Knee System due to improper packaging that compromises the sterile barrier. Incorrect carton sizing forced the device pouch to be folded, creating creases that breach the sterile protection.
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 a Class II medical device recall involving a compromised sterile barrier on an implantable orthopedic device. No illnesses or injuries have been reported, but sterile barrier compromise on an implanted device represents a risk-of-harm product where potential contamination has not yet resulted in reported injury.
Plain-English summary
Biomet, Inc. is recalling 7 units of the Oxford Partial Knee System, Fixed Lateral Tibial Construct (Item Number 154341), a medical device intended to replace part of a knee joint when used with femoral and tibial components.
The recall was initiated because these units were packaged in an incorrect shelf carton. The outer carton is smaller than required, forcing the Tyvex pouch to be folded during packaging. This folding creates compound creases that compromise the sterile barrier of the device.
The affected units have Lot Number 077830 with UDI (01)05019279515349(17)241123(10)077830. They were distributed worldwide to the US states of Indiana and Kentucky, as well as Canada, New Zealand, Japan, and the Netherlands.
The recalled product
- Product
- Oxford Partial Knee System, Fixed Lateral Tibial Construct- Intended to replace part of a knee joint when used in conjunction with a femoral and tibial component Item Number: 154341
- Manufacturer
- Biomet, Inc.
- Hazard
- sterile-barrier-compromise
- contamination-risk
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: (01) 05019279515349 (17) 241123 (10) 077830 Lot Number: 077830
Distribution
Distributed nationwide across the United States.
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