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U.S. Department of Health and Human Services

Class 2 Device Recall Biomet

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  Class 2 Device Recall Biomet see related information
Date Initiated by Firm April 18, 2019
Create Date June 06, 2019
Recall Status1 Terminated 3 on September 10, 2020
Recall Number Z-1741-2019
Recall Event ID 82818
Product Classification Orthopedic manual surgical instrument - Product Code LXH
Product Biomet Oxford Partial Knee Phase 3 / Domed Lateral Femoral Drill Guide:
Item Number: 32-421930 System Domed Lateral Femoral Drill Guide Small
Code Information Lot Numbers: ZB160101 ZB160801 ZB160801 
Recalling Firm/
Zimmer Biomet, Inc.
1800 W Center St
Warsaw IN 46580-2304
For Additional Information Contact 411 Technical Services
Manufacturer Reason
for Recall
Incorrect raw material used by the supplier in the manufacturing of the screw component, which could potentially lead to corrosion.
FDA Determined
Cause 2
Nonconforming Material/Component
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.
Quantity in Commerce 15
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.