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U.S. Department of Health and Human Services

Class 2 Device Recall Bone Screw

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  Class 2 Device Recall Bone Screw see related information
Date Initiated by Firm January 10, 2017
Create Date February 16, 2017
Recall Status1 Terminated 3 on March 26, 2018
Recall Number Z-1220-2017
Recall Event ID 76375
510(K)Number K121589  
Product Classification Screw, fixation, bone - Product Code HWC
Product 1.5mm System, Cranio-maxillofacial Bone Screws 1.5 x 4mm HT SD X-DR Screw, Bone Screw
Code Information 95-6104- Item No.  530430- Lot 1.5x4mm HT SD X-DR Screw
Recalling Firm/
Zimmer Biomet, Inc.
56 E Bell Dr
Warsaw IN 46582-6989
For Additional Information Contact Customer Service
Manufacturer Reason
for Recall
The identification of the devices was non-conforming with off-centered slots and the no-go gage starting in the pilot hole.
FDA Determined
Cause 2
Under Investigation by firm
Action Zimmer Biomet initiated a voluntary recall of 1.5mm System due to identification of non-conformance with off-centered slots and the no-go gage starting in the pilot hole. One distributor with affected product outside of Zimmer Biomet control was notified via email and asked to return the affected product. This communication was sent on via e-mail on January 10, 2017. All product has been returned.There were 89 units in Zimmer Biomet control at the time the removal was initiated, however all 100 are now in Zimmer Biomet control. Customer Service Zimmer Biomet, Inc. P.O. Box 708 Warsaw, IN 46581-0708 Phone: 800-348-2759
Quantity in Commerce 11
Distribution Domestic: None VA/DOD: None Foreign: 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 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 = HWC and Original Applicant = BIOMET MICROFIXATION