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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/
Manufacturer		 Zimmer Biomet, Inc.
1800 W Center St
Warsaw IN 46580-2304
For Additional Information Contact 411 Technical Services
574-371-3071
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
Distribution CA, IN, LA, NM, NY, TX, WI Foreign: CANADA, AUSTRALIA, JAPAN, NETHERLANDS
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.
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