Zimmer Biomet Recalls Oxford Partial Knee Drill Guides Due to Corrosion Risk
Zimmer Biomet is recalling 15 Oxford Partial Knee drill guides because incorrect raw materials may cause the screw component to corrode.
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 is classified as FDA Class II and involves a risk-of-harm product (corrosion) where injury has not yet been reported, fitting the criteria for a High severity score.
Plain-English summary
Zimmer Biomet, Inc. is recalling 15 units of the Biomet Oxford Partial Knee Phase 3 / Domed Lateral Femoral Drill Guide (Item Number: 32-421930). The recall is due to the use of incorrect raw materials by the supplier in the manufacturing of the screw component, which could potentially lead to corrosion.
The affected units were distributed in California, Indiana, Louisiana, New Mexico, New York, Texas, and Wisconsin, as well as in Canada, Australia, Japan, and the Netherlands. The specific lot numbers involved are ZB160101 and ZB160801.
This is a Class II recall. The FDA has not reported any illnesses or injuries associated with this defect. Healthcare providers and facilities should stop using the affected devices and contact Zimmer Biomet for instructions on return or replacement.
The recalled product
- Product
- Biomet Oxford Partial Knee Phase 3 / Domed Lateral Femoral Drill Guide: Item Number: 32-421930 System Domed Lateral Femoral Drill Guide Small
- Manufacturer
- Zimmer Biomet, Inc.
- Hazard
- Affected units
- 15
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)
- Lot Numbers: ZB160101 ZB160801 ZB160801
Distribution
Part of a larger recall action
This product is one of 6 recalled by Zimmer 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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