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U.S. Department of Health and Human Services

Class 2 Device Recall Phoenix Antegrade Femoral Nail Instrument

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 Class 2 Device Recall Phoenix Antegrade Femoral Nail Instrumentsee related information
Date Initiated by FirmSeptember 13, 2017
Create DateFebruary 27, 2018
Recall Status1 Terminated 3 on April 21, 2020
Recall NumberZ-0774-2018
Recall Event ID 79146
Product Classification Orthopedic manual surgical instrument - Product Code LXH
Product14-442000S Antegrade Femoral Nail Instrument Kit, orthopedic instrument
Code Information Finished Lot order: M370490 M354450 M321540 M975460 M639280 M426760 M629950 M629930 M073530 M073540 M073550 M073560 M073570 M073580 M073590 M073600 M073610 M627490 M656470 M656580 M656590 M656600 M656610 M656620 M656640 M656660 M966880 M967050 M967060 M967070 M980260 M980270 M508490 M508410 M508500 M508450 M508480 M508520 M508470 M508510 M508460 
Recalling Firm/
Manufacturer		 Zimmer Biomet, Inc.
56 E Bell Dr
Warsaw IN 46582-6989
For Additional Information Contact411 Technical Services
574-371-8040
Manufacturer Reason
for Recall		Fracture of the bolt connecting the insertion guide to the intramedullary nail during insertion of the femoral nail.
FDA Determined
Cause 2		Device Design
ActionOn September 13, 2017 an URGENT MEDICAL DEVICE RECALL REMOVAL was issued to customers requesting that they review inventory and quarantine affected product, which will be immediately returned to recalling firm. Also to notify any customers who may have received product. Questions or concerns can be directed to Customer Service at 574-371-3071
Quantity in Commerce337 total
DistributionDistribution includes US Nationwide.
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.
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