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U.S. Department of Health and Human Services

Class 2 Device Recall Regenerex" Tibial Components

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  Class 2 Device Recall Regenerex" Tibial Components see related information
Date Initiated by Firm September 04, 2020
Create Date October 08, 2020
Recall Status1 Open3, Classified
Recall Number Z-0081-2021
Recall Event ID 86424
510(K)Number K080361  
Product Classification Prosthesis, knee, patello/femorotibial, semi-constrained, uncemented, porous, coated, polymer/metal/polymer - Product Code MBH
Product Biomet Regenerex Primary Taper Cap
Item Number 141269
Code Information Lot Numbers: 015800 324440 685300 023900 324440R 696280 058930 389060 821980 200720 418430 890320 313260 646040 997610
Recalling Firm/
Manufacturer
Biomet, Inc.
56 E Bell Dr
Warsaw IN 46582-6989
For Additional Information Contact 411 Technical Services
574-371-3071
Manufacturer Reason
for Recall
Product not properly being aligned with the adequate gamma sterilization group and result in the product not being properly sterilized
FDA Determined
Cause 2
Process change control
Action Zimmer Biomet notified on 9/2/20 Distributors with direct sales and/or fielded inventory via email and traceable letter sent via FedEx. Hospitals with direct sales or current inventory, as well as hospitals that have consumed products in the past 12 months will be notified via FedEx. Surgeons that have consumed products with in the past 12 months notified via FedEx. Risk Manager Responsibilities: 1. Review this notification and ensure that affected personnel are aware of the contents. 2. If you have affected product at your facility, assist your Zimmer Biomet sales representative and quarantine all affected product. Your Zimmer Biomet sales representative will remove the affected product from your facility. 3. Complete Attachment 1  Certificate of Acknowledgement and send to CorporateQuality.PostMarket@zimmerbiomet.com. This form will be returned even if you do not have affected products at your facility. 4. Retain a copy of the acknowledgement form with your recall records in the event of a compliance audit of your facilitys documentation. 5. If you have further 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. Calls received outside of call center operating hours will receive a voicemail prompt or be transferred to an on-call representative in the event of an emergency. Alternatively, your questions may be emailed to CorporateQuality.PostMarket@zimmerbiomet.com. Surgeon Responsibilities: 1. Review this notification for awareness of the contents. 2. There are no specific patient monitoring instructions related to this recall that are recommended beyond your existing follow-up schedule. 3. Complete Attachment 1  Certificate of Acknowledgement and send to CorporateQuality.PostMarket@zimmerbiomet.com. 4. Retain a copy of the acknowledgement form with your recall records in the event of a compliance audit of your facilitys documentation. 5. If you ha
Quantity in Commerce US: 62 units; OUS: 176 units
Distribution Nationwide Foreign: Canada, FINLAND, NETHERLANDS, UNITED KINGDOM
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = MBH and Original Applicant = BIOMET, INC.
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