Z-0958-2019 Class II Terminated
FDA device recall Z-0958-2019 was initiated by Exactech, Inc. on Dec 5, 2018 and is designated Class II. 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… The recall status is terminated (terminated Apr 29, 2021). Affected quantity: 40 devices.
Recall Details
- Product Type
- Devices
- Report Date
- Mar 6, 2019
- Initiation Date
- Dec 5, 2018
- Termination Date
- Apr 29, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 40 devices
Product Description
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.
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 .
Distribution Pattern
US Nationwide distribution in the states of AL,FL, IA, LA, MD, OH, SC.
Code Information
Catalog Number: 300-30-08; UDI: 10885862515766; Serial Numbers: 5569566, 5569576, 5569579, 5569582, 5569584, 5569586, 5569589, 5569595.
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0958-2019
- openFDA file date
- Oct 21, 2026
- Loaded by RegDataLab
- Oct 23, 2026