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U.S. Department of Health and Human Services

Class 2 Device Recall Exactech GPS Total Shoulder Application 3.2mm Vix Bit

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  Class 2 Device Recall Exactech GPS Total Shoulder Application 3.2mm Vix Bit see related information
Date Initiated by Firm July 11, 2017
Date Posted January 18, 2018
Recall Status1 Terminated 3 on April 22, 2021
Recall Number Z-0603-2018
Recall Event ID 78064
510(K)Number K162567  
Product Classification Orthopedic stereotaxic instrument - Product Code OLO
Product Exactech GPS Total Shoulder Application 3.2mm Vix Bit Orthopedic surgical tool
Code Information Catalog No. 531-15-08, Lot No. 75296003, 80129003, 81327001
Recalling Firm/
Manufacturer		 Exactech, Inc.
2320 NW 66th Ct
Gainesville FL 32653-1630
For Additional Information Contact Kaya Davis
800-392-2832
Manufacturer Reason
for Recall		 Vix Bit may fracture during use.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action Customers were notified on approximately 07/11/2017. Instructions included cease distribution of the affected product, notify customers if further distributed, identify and quarantine any product in inventory and complete and return the Recall Inventory Response Form. For further questions, please call (800) 392-2832.
Quantity in Commerce 41 devices
Distribution Worldwide Distribution: US states of Florida and California, Australia, France, Spain, and United Kingdom.
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 = OLO and Original Applicant = Blue Ortho
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