Z-0958-2019Class II

Equinoxe Preserve Humeral Stem, 8mm

Name: Z-0958-2019 Equinoxe Preserve Humeral Stem, 8mm
Creator: Exactech, Inc.
Published: 2018-12-05
License: https://open.fda.gov/license/

Exactech, Inc. / initiated 2018-12-05 / Terminated / root cause: packaging

FDA source

Exactech, Inc. began a recall of Equinoxe Preserve Humeral Stem, 8mm Product Usage: The Equinoxe Preserve Stems are indicated for use in skeletally mature individuals with degenerative... on 2018-12-05. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0958-2019
Classification: Class II
Status: Terminated
Initiated: 2018-12-05
Posted: 2019-02-26
Terminated: 2021-04-29
Recalling firm: Exactech, Inc.
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.
Product code: PHX Shoulder Prosthesis, Reverse Configuration
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 .
Root cause tag: packaging
FDA root 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.
Product codes and lots: Catalog Number: 300-30-08; UDI: 10885862515766; Serial Numbers: 5569566, 5569576, 5569579, 5569582, 5569584, 5569586, 5569589, 5569595.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0958-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0958-2019	Class II	Terminated	Voluntary: Firm initiated	2019-03-06	2019-02-26

Product code PHX

K162726Class IIExactech® Equinoxe® Preserve StemExactech, Inc. / cleared 2017-02-01

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)