The Recall Desk
HighFDA (Devices)·Z-1739-2019·Announced 2019-06-12

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.

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 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
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

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 →