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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 December 01, 2020
Create Date December 23, 2020
Recall Status1 Open3, Classified
Recall Number Z-0723-2021
Recall Event ID 86923
510(K)Number K093293  
Product Classification Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer - Product Code JWH
Product Vanguard 360 Revision System Posterior Augment With Bolt - Product Usage: intended for use in knee arthroplasty

Item Number: 185422

Code Information Lot Number: 098780  UDI Number: (01) 00880304482739 (17) 290501 (10) 098780
Recalling Firm/
Manufacturer
Biomet, Inc.
56 E Bell Dr
Warsaw IN 46582-6989
For Additional Information Contact 411 Technical Services
574-372-1687
Manufacturer Reason
for Recall
Incorrect bolt -tibial bolts in package instead of femoral bolts may delay procedure
FDA Determined
Cause 2
Process control
Action .Zimmer Biomet issued Urgent Medical Device Recall letter issued on 12/1/20 to distributors with direct sales and/or fielded inventory via email and traceable letter sent via FedEx. Hospitals with direct sales or current inventory will be notified via FedEx. Letter states reason for recall , health risk and action to take: Distributors esponsibilities include: locating and removing the product in their territory, as well as identifying hospitals who have previously used the product. 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. If the product has been further distributed, provide your customers with the field safety notice for hospitals and ensure documentation. 4. Complete Attachment 1  Certificate of Acknowledgement and send to CorporateQuality.PostMarket@zimmerbiomet.com. This form shall be returned even if you do not have affected products at your facility. 5. Retain a copy of the acknowledgement form with your recall records in the event of a compliance audit of your facilitys documentation. 6. 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.
Quantity in Commerce 21 units
Distribution Worldwide distribution - US Nationwide distribution in the state of FL and the countries of Korea, 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 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 = JWH and Original Applicant = BIOMET, INC.
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