Biomet Oxford Partial Knee Systems Recalled for Elevated Endotoxin Levels
Biomet, Inc. is recalling 76 units of Oxford Partial Knee Systems due to potential endotoxin levels exceeding specification limits.
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: The recall involves a medical device with a potential contamination hazard (endotoxin) that could cause harm, but no specific injuries or illnesses are reported in the source text, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Biomet, Inc. is recalling 76 units of Oxford Partial Knee Systems, including various fixed lateral tibial constructs and anatomic meniscal bearings. The recall is due to the potential presence of elevated endotoxin levels that exceed the specification limit.
The affected products were distributed worldwide, including in the United States, Canada, and various countries in Asia, Europe, and South America. The specific lot numbers and UDI numbers for the affected units are listed in the official recall documentation.
Consumers and healthcare providers should contact Biomet, Inc. for further information regarding the recall and available remediation options. Patients who have received these implants should consult with their healthcare provider for guidance.
The recalled product
- Product
- Knee Products: 154335 Oxford Partial Knee System, Fixed Lateral Tibial Construct, Left, Cemented, D3 154336 Oxford Partial Knee System, Fixed Lateral Tibial Construct, Left, Cemented, D4 154339 Oxford Partial Knee System, Fixed Lateral Tibial Construct, Left, Cemented, D7 154
- Manufacturer
- Biomet, Inc.
- Hazard
- Affected units
- 76
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 (8)
- Lot Numbers: Product UDI Number 666130 Knees Oxford Partial Knee System
- Fixed Lateral Tibial Construct
- Left
- Cemented
- Right
- Right Medial
- Medium
- 3 MM (01)05019279786213(17)211228(10)374340
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 13 recalled by Biomet, 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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