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U.S. Department of Health and Human Services

Class 2 Device Recall Humeral Stem

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  Class 2 Device Recall Humeral Stem see related information
Date Initiated by Firm December 05, 2018
Create Date February 26, 2019
Recall Status1 Terminated 3 on April 29, 2021
Recall Number Z-0958-2019
Recall Event ID 82025
510(K)Number K162726  
Product Classification shoulder prosthesis, reverse configuration - Product Code PHX
Product Equinoxe Preserve Humeral Stem, 8mm

Product Usage:
The Equinoxe Preserve Stems are indicated for use in skeletally mature individuals with degenerative diseases of the glenohumeral joint where anatomic total arthroplasty,anatomic hemi-arthroplasty,or reverse total arthroplasty is determined by the surgeon to be the preferred method of treatment. The Equinoxe Preserve Stems are additionally indicated for use in reverse total arthroplasty in skeletally mature individuals with degenerative diseases of the glenohumeral joint and a grossly deficient, irreparable rotator cuff or a failed glenohumeral joint replacement with loss of rotator cuff function resulting in superior migration of the humeral head. The patient must be anatomically and structurally suited to receive the implants and a functional deltoid muscle is necessary. The Equinoxe Preserve Stems are intended for press-fit applications but may be used with bone cement at the discretion of the surgeon.
Code Information Catalog Number: 300-30-08;  UDI: 10885862515766;  Serial Numbers: 5569566, 5569576, 5569579, 5569582, 5569584, 5569586, 5569589, 5569595. 
Recalling Firm/
Manufacturer		 Exactech, Inc.
2320 NW 66th Ct
Gainesville FL 32653-1630
For Additional Information Contact
352-377-1140
Manufacturer Reason
for Recall		 Possibility that the Equinoxe Preserve Humeral Stem, 8mm, was inadvertently packaged with an Optetrak Knee System instructions for use (IFU) rather than the Equinoxe Preserve Humeral Stem IFU as intended .
FDA Determined
Cause 2		 Packaging
Action On about 12/05/2018, Exactech notified customers via "URGENT MEDICAL DEVICE RECALL" notification sent through email. Instructions included to immediately cease distribution or use of affected products, provide the recall information to customers if further distributed, identify and quarantine any affected devices in inventory, complete and return the Recall Acknowledgement Form, and make arrangements to return affected devices to Exactech.
Quantity in Commerce 40 devices
Distribution US Nationwide distribution in the states of AL,FL, IA, LA, MD, OH, SC.
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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