Recall Z-1741-2019— Zimmer Biomet, Inc.

Name: FDA recall Z-1741-2019
Creator: U.S. Food and Drug Administration
Published: 2019-04-18

Class II · Terminated

Class II FDA medical device recall by Zimmer Biomet, Inc., initiated 2019-04-18, terminated 2020-09-10. FDA's recall record names no specific 510(k) clearance for this event. Product: Biomet Oxford Partial Knee Phase 3 / Domed Lateral Femoral Drill Guide: Item Number: 32-421930 System Domed Lateral Femoral Drill Guide Small. Reason: Incorrect raw material used by the supplier in the manufacturing of the screw component, which could potentially lead to corrosion..

Recalling firm: Zimmer Biomet, Inc.
Classification: Class II
Status: Terminated
Initiated: 2019-04-18
Terminated: 2020-09-10
Firm location: Warsaw, IN, United States

Product description

Biomet Oxford Partial Knee Phase 3 / Domed Lateral Femoral Drill Guide: Item Number: 32-421930 System Domed Lateral Femoral Drill Guide Small

Reason for recall

Incorrect raw material used by the supplier in the manufacturing of the screw component, which could potentially lead to corrosion.

Data sourced from openFDA. This site is unofficial and independent of the FDA.