The Recall Desk
HighFDA (Devices)·Z-1740-2019·Announced 2019-06-12

Zimmer Biomet Recalls Oxford Partial Knee Drill Guides Due to Corrosion Risk

Zimmer Biomet is recalling 14 units of Oxford Partial Knee Phase 3 Femoral Drill Guides because incorrect raw materials were used, potentially leading to corrosion.

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 the hazard involves a risk of harm (corrosion) in a medical device where injury has not yet been reported, fitting the 'High' severity criteria.

Plain-English summary

Zimmer Biomet, Inc. is recalling 14 units of the Biomet Oxford Partial Knee Phase 3 / Domed Lateral Femoral Drill Guide (Item Number: 32-421060 Phase 3 Femoral Drill Guide Extra Small). The recall was initiated because the supplier used incorrect raw material 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 ZB160601, ZB170201, and ZB170601.

This is a Class II recall, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences. The FDA has not reported any illnesses or injuries associated with this recall. Healthcare providers and patients should contact Zimmer Biomet for instructions on how to return or replace the affected devices.

The recalled product

Product
Biomet Oxford Partial Knee Phase 3 / Domed Lateral Femoral Drill Guide: Item Number: 32-421060 Phase 3 Femoral Drill Guide Extra Small
Manufacturer
Zimmer Biomet, Inc.
Category
Medical Device — Orthopedic Implant
Hazard
Affected units
14

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: ZB160601 ZB170201 ZB170201 ZB170601

Distribution

Distributed in 7 states:

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.

See all 6 products in this recall →

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