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U.S. Department of Health and Human Services

Class 2 Device Recall Biomet RingLoc Hip System SelfTapping Bone Screw

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  Class 2 Device Recall Biomet RingLoc Hip System SelfTapping Bone Screw see related information
Date Initiated by Firm March 01, 2019
Create Date April 04, 2019
Recall Status1 Terminated 3 on May 27, 2020
Recall Number Z-1086-2019
Recall Event ID 82332
510(K)Number K912245  
Product Classification Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer - Product Code JWH
Product Biomet RingLoc Hip System Self-Tapping Bone Screw 6.5mmx20mm-Low Profile Titanium. Accessory to total hip implant
Item Number: 103531

Product Usage:
Accessory to total hip implant
Code Information Lot Numbers/UDI Number 523430 (01) 00880304001961 (17) 280804 (10) 523430 523450 (01) 00880304001961 (17) 280727 (10) 523450 860840 (01) 00880304001961 (17) 280806 (10) 860840 860850 (01) 00880304001961 (17) 280809 (10) 860850 860860 (01) 00880304001961 (17) 280806 (10) 860860
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 lengths of the 6.5mm RingLoc Hip System Self-Tapping Bone Screw may have the potential for the 30mm screws to be packaged as 20mm screws and vice versa.
FDA Determined
Cause 2		 Packaging process control
Action Zimmer Biomet conducted recall by letter dated 3/1/19 to the consumer/user level, including any intermediate wholesale or retail consignees. All distributors via email. Hospital risk managers and surgeons, as well as distributors with product notified Fed'x. Accounts asked to review notification and ensure that affected team members are aware of the contents. 2. Immediately locate and quarantine affected product in your inventory.3. Immediately return all affected product from your distributorship and from affected hospitals within your territory.a. Complete Attachment 1  Inventory Return Certification Form. 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 809 total
Distribution Worldwide Distribution - US Nationwide Foreign: CHILE CHINA COSTA RICA GUJRAT,INDIA JAPAN MEXICO CDMX SINGAPORE
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 = JWH and Original Applicant = BIOMET, INC.
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