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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 Screwsee related information
Date Initiated by FirmJanuary 10, 2017
Create DateFebruary 16, 2017
Recall Status1 Terminated 3 on March 26, 2018
Recall NumberZ-1220-2017
Recall Event ID 76375
510(K)NumberK121589 
Product Classification Screw, fixation, bone - Product Code HWC
Product1.5mm 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/
Manufacturer		 Zimmer Biomet, Inc.
56 E Bell Dr
Warsaw IN 46582-6989
For Additional Information ContactCustomer Service
800-348-2759
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
ActionZimmer 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 Commerce11
DistributionDomestic: None VA/DOD: None Foreign: Japan
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = HWC
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