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U.S. Department of Health and Human Services

Class 2 Device Recall Equinoxe Cage, Glenoid, Alpha, Medium

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  Class 2 Device Recall Equinoxe Cage, Glenoid, Alpha, Medium see related information
Date Initiated by Firm August 31, 2017
Date Posted January 18, 2018
Recall Status1 Terminated 3 on August 06, 2019
Recall Number Z-0415-2018
Recall Event ID 78903
510(K)Number K113309  
Product Classification Prosthesis, shoulder, semi-constrained, metal/polymer cemented - Product Code KWS
Product Equinoxe Cage, Glenoid, Alpha, Medium

Product Usage:
The Equinoxe Shoulder System is indicated for use in skeletally mature individuals with degenerative diseases or fractures of the glenohumeral joint where total or hemi- arthroplasty is determined by the surgeon to be the preferred method of treatment.
Code Information Catalog #: 314-13-03 Serial Range: 5013020 - 5013049
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
Potentially mislabeled.
FDA Determined
Cause 2
Under Investigation by firm
Action Consignees were sent a Recall Notice dated 8/31/2017 by mail informing them of the potential mislabel. The notice requested consignees: Immediately cease distribution/use of this product; Extend information to accounts in possession of the product; Identify and quarantine any subject devices in their inventory; Complete and return Recall Acknowledgement and Recall Inventory Response Forms. For further questions please call (800) 392-2832.
Quantity in Commerce 30
Distribution Worldwide distribution in the states of OH, WI, AZ, GA, VA, CA, OK, MN, TN, ME, CO, SC, FL, AL, and Puerto Rico and country of Switzerland
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 = KWS and Original Applicant = EXACTECH, INC.
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