Biomet Oxford Femoral Drill Guide Recalled for Undersized Diameter
Biomet is recalling 18 Oxford Femoral Drill Guide Lateral IM Adapters because an undersized diameter may interfere with a specific IM Link component.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, which is a moderate risk. The source text describes a mechanical interference issue but does not report any injuries, illnesses, or deaths, fitting the criteria for a moderate severity score.
Plain-English summary
Biomet, Inc. is recalling 18 units of the Oxford Femoral Drill Guide Lateral IM Adapter. The recall is due to a potential defect where the adapter may have an undersized diameter. This issue can cause an interference with the Oxford Microplasty IM Link (Part Number: 32-422822).
The affected product is a drill guide used in the Oxford Fixed Bearing Knee system, which is a partial knee replacement system for the lateral compartment of the knee. The specific part number for the recalled adapter is 32-423400. The affected lot numbers are 238220, 664720, 489620, 490930, 021410, and 507150.
The affected units were distributed worldwide, including in the United States (North Carolina, Indiana, Pennsylvania, and Ohio) and the Netherlands. Healthcare providers and facilities should stop using the affected adapters and contact Biomet for further instructions.
The recalled product
- Product
- Oxford Femoral Drill Guide Lateral IM Adapter Product Usage: Drill guide. The Oxford Fixed Bearing Knee is a Partial knee replacement system consisting of a femoral component and a fixed bearing tibial component for use in the lateral compartment of the knee. Partial…
- Manufacturer
- Biomet, Inc.
- Hazard
- Affected units
- 18
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 (6)
- Part Number: 32-423400 Lot Numbers: 238220
- 664720
- 489620
- 490930
- 021410
- 507150
Distribution
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