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U.S. Department of Health and Human Services

Class 2 Device Recall Biomet Hip System

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  Class 2 Device Recall Biomet Hip System see related information
Date Initiated by Firm April 02, 2018
Create Date April 27, 2018
Recall Status1 Terminated 3
Recall Number Z-1537-2018
Recall Event ID 79685
510(K)Number K911684  
Product Classification Prosthesis, hip, semi-constrained, metal/polymer, cemented - Product Code JDI
Product Modular Head Component, Biomet Hip System; Item No. 163669, Hip Joint, metal/polymer semi-constrained cemented prosthesis

The device is used in treatment of patients who need total hip arthroplasty, and consists of modular components and corresponding instruments.
Code Information lot 276760
Recalling Firm/
Manufacturer
Zimmer Biomet, Inc.
56 E Bell Dr
Warsaw IN 46582-6989
For Additional Information Contact 411 Technical Services
574-371-3071
Manufacturer Reason
for Recall
Two lots of different sized modular heads potentially commingled. Risks include delay in surgery and dislocation due to use of an incorrect sized head.
FDA Determined
Cause 2
Nonconforming Material/Component
Action The firm, Zimmer Biomet, sent an "URGENT MEDICAL DEVICE RECALL" letter dated 4/2/2018 to its customers. The letter described the product, problem and actions to be taken. Distributors will be notified of the recall via email. Hospital risk managers and distributors with product will be notified via courier. The distributor letter includes instructions to locate and remove the product in their territory, identify hospitals who have previously used the product; return on-hand product to the recalling firm and ensure all products are accounted for. The letter for hospital risk managers instruct the risk managers to assist the recalling firm's sales reps with quarantine of the product; to review notification and ensure affected personnel are aware of the contents; and complete and return the Certificate of Acknowledgement form to CorporateQuality.PostMarket@zimmerbiomet.com, even if you do not have product, and retain a copy. Customers with questions are directed to call customer service at 574-371-3071 between 8AM-5PM EST, Monday through Friday. Alternatively, questions may be emailed to CorporateQuality.PostMarket@zimmerbiomet.com.
Quantity in Commerce 30
Distribution Worldwide Distribution: US (nationwide) in states of: AL, AR, FL, GA, IN, KY, LA, MO, MS, OH, OK, TX, and VA; and countries of: Canada, Costa Rica and Chile.
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.
510(K) Database 510(K)s with Product Code = JDI and Original Applicant = BIOMET, INC.
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