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U.S. Department of Health and Human Services

Class 2 Device Recall Biomet DVR Crosslock Screws

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  Class 2 Device Recall Biomet DVR Crosslock Screws see related information
Date Initiated by Firm November 20, 2018
Create Date January 10, 2019
Recall Status1 Open3, Classified
Recall Number Z-0708-2019
Recall Event ID 81704
510(K)Number K112345  
Product Classification Appliance, fixation, nail/blade/plate combination, multiple component, metal composite - Product Code LXT
Product Biomet DVR Crosslock Screws- 2.7mm x 20mm, Sterile

ITEM 131827120

Product Usage:
The system is intended for stabilization and fixation of small bone fragments in fresh fractures, revision procedures, joint fusion and reconstructions (osteotomies) of small bones of the hand, foot, radius, ulna, ankle, humerus, scapula and pelvis, particularly in osteopenic bone
Code Information LOT 029980 UDI (01)00880304535589(17)280501(10)029980
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
One lot of product labeled 2.7mm x18mm Lock Screw Square Drive (Lot 029970) contains 20mm locking screws and one lot of product labeled 2.7mm x 20mm Lock Screw Square Drive (Lot 029980) contains 18mm locking screws
FDA Determined
Cause 2
Packaging process control
Action Zimmer Biomet issued Urgent Medical Device Recall letter on 11/20/18 advising of the problem, heath risk and action to be taken- Quarantine and return product. Complete Attachment 1 Certificate of Acknowledgement. Contact customer service at 574-371-3071 between 8:00 am and 5:00pm EST, Monday through Friday.
Quantity in Commerce 50 pieces
Distribution Country of Japan
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 = LXT and Original Applicant = MEDOS INTERNATIONAL SARL
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