The Recall Desk
HighFDA (Devices)·Z-1738-2019·Announced 2019-06-12

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

Zimmer Biomet is recalling 11 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 involves a medical device with a potential for corrosion, which is a risk-of-harm product where injury has not yet been reported, fitting the criteria for a High severity score.

Plain-English summary

Zimmer Biomet, Inc. is recalling 11 units of Biomet Oxford Partial Knee Phase 3 / Domed Lateral Femoral Drill Guides (Item Number: 32-420323). The recall is due to the use of incorrect raw material by the supplier in the manufacturing of the screw component, which could potentially lead to corrosion.

The affected units are 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 ZB161102, ZB170201, ZB170301, ZB170401, and ZB170901.

Healthcare providers and patients should contact Zimmer Biomet for further instructions regarding the return or replacement of these devices.

The recalled product

Product
Biomet Oxford Partial Knee Phase 3 / Domed Lateral Femoral Drill Guide: Item Number: 32-420323 Phase 3 Femoral Drill Guide Large
Affected units
11

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: ZB161102 ZB170201 ZB170301 ZB170401 ZB170901

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 →