The Recall Desk
HighFDA (Devices)·Z-1736-2019·Announced 2019-06-12

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

Zimmer Biomet is recalling 41 Oxford Partial Knee Phase 3 Femoral Drill Guides because incorrect raw material was used in the screw component, which could lead 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. The hazard involves a potential for corrosion in a medical device, which poses a risk of harm, but the source text does not report any actual injuries or illnesses, fitting the criteria for a High severity score.

Plain-English summary

Zimmer Biomet, Inc. is recalling 41 units of the Biomet Oxford Partial Knee Phase 3 / Domed Lateral Femoral Drill Guide (Item Number: 32-420321 Phase 3 Femoral Drill Guide Small). The recall was initiated because the supplier used incorrect raw material in the manufacturing of the screw component. This defect could potentially lead to corrosion of the device.

The affected units were distributed in the United States to California, Indiana, Louisiana, New Mexico, New York, Texas, and Wisconsin. The products were also distributed to Canada, Australia, Japan, and the Netherlands. The specific lot numbers involved in this recall are ZB160201, ZB160401, ZB161101, ZB170401, ZB170601, ZB170801, and ZB170901.

Healthcare providers and patients who have received these specific drill guides should contact Zimmer Biomet, Inc. for further instructions on how to handle the recalled devices. The source text does not report any illnesses or injuries associated with this recall.

The recalled product

Product
Biomet Oxford Partial Knee Phase 3 / Domed Lateral Femoral Drill Guide: Item Number: 32-420321 Phase 3 Femoral Drill Guide Small
Affected units
41

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 →