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Terminated

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

FDA Recall Z-1738-2019 · Posted None

Recalling FirmZimmer Biomet, Inc.
Recall StatusTerminated
Product CodeLXH
Date Initiated2019-04-18
Date Terminated2020-09-10
Product Quantity11 units

Reason for Recall

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

Firm Action

Zimmer Biomet issued URGENT MEDICAL DEVICE RECALL notification to distributors and hospital risk managers on 4/18/19 via FedEX and email. " Distributors letter identifies the issue and responsibilities include locating and removing the product in their territory, as well as identifying hospitals who have previously used the product. " Distributors will return on-hand product to Zimmer Biomet and ensure all of their products are accounted for using the form provided in the letter. " Hospital risk managers will be provided with a letter identifying the issue and their responsibilities. Complete Certificate of Acknowledgement. questions or concerns after reviewing this notice, please call customer service at 574-371-3071 between 8:00 am and 5:00pm EST, Monday through Friday.

Root Cause

Nonconforming Material/Component

Distribution Pattern

CA, IN, LA, NM, NY, TX, WI Foreign: CANADA, AUSTRALIA, JAPAN, NETHERLANDS

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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