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U.S. Department of Health and Human Services

Class 2 Device Recall Exactech Equinoxe Platform Fracture Stem

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  Class 2 Device Recall Exactech Equinoxe Platform Fracture Stem see related information
Date Initiated by Firm December 03, 2019
Create Date January 28, 2020
Recall Status1 Open3, Classified
Recall Number Z-0872-2020
Recall Event ID 84532
510(K)Number K101909  
Product Classification shoulder prosthesis, reverse configuration - Product Code PHX
Product Exactech equinoxe PLATFORM FRACTURE, HUMERAL STEM, CEMENTED, Right, 6.5mm, REF 304-22-07 - Product Usage: The Equinoxe Shoulder System is indicated for use and in skeletally mature individuals with degenerative diseases or fractures of the glenohumeral joint work total or hemi- arthroplasty is determined by the surgeon to be the preferred method of treatment.




Code Information All lot numbers in OUS distribution.  
Recalling Firm/
Manufacturer
Exactech, Inc.
2320 NW 66th Ct
Gainesville FL 32653-1630
For Additional Information Contact Priscella Bennett Jones
352-377-1140
Manufacturer Reason
for Recall
Labels with incorrect translations were identified by Exactech is a distributor in the Netherlands. The translations on the outer labels include the word " long" in all languages other than the original English version. The implants are standard length fracture stems.
FDA Determined
Cause 2
Under Investigation by firm
Action The firm notified its direct accounts by email on 12/03/2019. The notice instructed the consignees to provide the field safety notice to all those within their organization or to any organization where the potentially affected device have been transferred.
Quantity in Commerce 2,910 devices
Distribution International distribution in the countries of Australia; Austria; Brazil; Canada; China; Colombia: France; Germany; Guatemala, India; Italy; Japan; Luxembourg; Netherlands; Singapore; South Korea; Spain; Sweden: 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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = PHX and Original Applicant = EXACTECH, INC.
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