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Terminated

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.

FDA Recall Z-0958-2019 · Posted None

Recalling FirmExactech, Inc.
Recall StatusTerminated
Product CodePHX
Date Initiated2018-12-05
Date Terminated2021-04-29
Product Quantity40 devices

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 .

Firm 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.

Root Cause

Packaging

Distribution Pattern

US Nationwide distribution in the states of AL,FL, IA, LA, MD, OH, SC.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K162726Exactech® Equinoxe® Preserve StemExactech, Inc. · 2017-02-01

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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