The Recall Desk
HighFDA (Devices)·Z-1737-2019·Announced 2019-06-12

Zimmer Biomet Recalls Oxford Partial Knee Drill Guides Due to Material Error

Zimmer Biomet is recalling 10 units of Oxford Partial Knee Phase 3 Femoral Drill Guides because incorrect raw material was 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 potential material defect (corrosion) in a medical device where injury has not yet been reported, fitting the 'High' severity criteria for risk-of-harm products.

Plain-English summary

Zimmer Biomet, Inc. is recalling 10 units of the Biomet Oxford Partial Knee Phase 3 / Domed Lateral Femoral Drill Guide (Item Number: 32-420322, Phase 3 Femoral Drill Guide Medium). 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, identified by Lot Number ZB130801, were distributed to facilities in California, Indiana, Louisiana, New Mexico, New York, Texas, and Wisconsin, as well as to Canada, Australia, Japan, and the Netherlands. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

Healthcare providers and facilities that have received these specific drill guides should stop using them and contact Zimmer Biomet for instructions on how to return the devices. Patients who have already had surgery using these guides should contact their surgeon if they have concerns regarding the integrity of the implant components.

The recalled product

Product
Biomet Oxford Partial Knee Phase 3 / Domed Lateral Femoral Drill Guide: Item Number: 32-420322 Phase 3 Femoral Drill Guide Medium
Manufacturer
Zimmer Biomet, Inc.
Category
Medical Device — Orthopedic Implant
Hazard
Affected units
10

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: ZB130801

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 →

Related recalls

Same manufacturer · Zimmer Biomet, Inc.

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Same hazard · corrosion

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