Zimmer Biomet Recalls Oxford Partial Knee Drill Guides Due to Corrosion Risk
Zimmer Biomet is recalling 3 units of Oxford Partial Knee Phase 3 Femoral Drill Guides because incorrect raw materials may cause corrosion.
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 3/5 (High).
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 for corrosion, which poses a risk of harm, but no injuries or illnesses have been reported in the source text.
Plain-English summary
Zimmer Biomet, Inc. is recalling 3 units of Biomet Oxford Partial Knee Phase 3 / Domed Lateral Femoral Drill Guides (Item Number: 32-420324). 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 are identified by Lot Number ZB110301. These products were distributed in California, Indiana, Louisiana, New Mexico, New York, Texas, and Wisconsin, as well as in Canada, Australia, Japan, and the Netherlands.
Consumers and healthcare providers 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: 32-420324Phase 3 Femoral Drill Guide Extra Large
- Manufacturer
- Zimmer Biomet, Inc.
- Hazard
- Affected units
- 3
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: ZB110301
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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