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U.S. Department of Health and Human Services

Class 2 Device Recall Ringloc CoCr Modular Femoral Heads

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  Class 2 Device Recall Ringloc CoCr Modular Femoral Heads see related information
Date Initiated by Firm September 15, 2017
Create Date March 14, 2018
Recall Status1 Terminated 3 on August 20, 2018
Recall Number Z-1008-2018
Recall Event ID 79254
510(K)Number K032396  
Product Classification Prosthesis, hip, semi-constrained, metal/polymer, cemented - Product Code JDI
Product 36MM COCR MODULAR HD -6MM
Code Information 11-363660 UDI Number: (01) 00880304210509 (17) 270507 (10) 236840  Product Number: 11-363660 Lot Number: 236840
Recalling Firm/
Manufacturer		 Zimmer Biomet, Inc.
56 E Bell Dr
Warsaw IN 46582-6989
Manufacturer Reason
for Recall		 One piece from a different lot mixed with lot 236840 and is incorrectly etched as -6MM offset instead of +3MM offset. As the incorrect etching and related size difference affects the functional use of this product, the affected lot is being removed from the field.
FDA Determined
Cause 2		 Error in labeling
Action Foreign risk managers were emailed notification of recall with the following instructions: 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 must 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.
Quantity in Commerce 23
Distribution Outside USA
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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