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U.S. Department of Health and Human Services

Class 2 Device Recall Equinoxe

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  Class 2 Device Recall Equinoxe see related information
Date Initiated by Firm September 25, 2020
Create Date October 29, 2020
Recall Status1 Terminated 3 on May 01, 2023
Recall Number Z-0307-2021
Recall Event ID 86590
510(K)Number K092900  K101909  
Product Classification shoulder prosthesis, reverse configuration - Product Code PHX
Product Equinoxe Platform Fracture Stem, 6.5mm, Left - Product Usage: The Equinoxe Platform Fracture Stem is indicated for cemented use only.
Code Information Catalog: 304-21-07; Serial Ranges: 4968615-4968627; 4952421-4952432
Recalling Firm/
Manufacturer		 Exactech, Inc.
2320 NW 66th Ct
Gainesville FL 32653-1630
For Additional Information Contact Courtney Senter
352-377-1140
Manufacturer Reason
for Recall		 The device may be incorrectly laser marked as a right stem, when it should have been laser marked as a left stem.
FDA Determined
Cause 2		 Process control
Action The recalling firm distributed a recall notice to US consignees with affected inventory on 09/25/2020. The recall notice was translated and provided to OUS consignees on 10/082020. Consignees have been instructed to: -Immediately cease distribution or use of this product -Extend the information to their accounts that may have this product in their possession. -Identify and quarantine any of the subject devices in their inventory. -Complete and return the Recall Inventory Response Form to Exactech.
Quantity in Commerce 25 devices
Distribution Worldwide distribution - US Nationwide distribution including in the states of CA, CO, FL, IN, KY, NY, OH, TX, and Puerto Rico. The countries of Australia, Germany, France, Spain, India, Italy, South Korea, Singapore, UK, Luxembourg, and Brazil.
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 = PHX and Original Applicant = EXACTECH, INC.
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