U.S. Food and Drug Administration recently issued the following announcement.
Date Initiated by Firm: December 05, 2018
Create Date: February 26, 2019
Recall Status Open, Classified
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 Recal: lPossibility 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: 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
Original source can be found here.
