Exactech, Inc. recalls Equinoxe Preserve Humeral Stem, 8mm Product Usage: The Equinoxe Preserve Stems are indicated for use in skeletally matu…

Recall date

December 5, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0958-2019

FDA classification

Class II

Brand / firm

Exactech, Inc.

Sold / distributed

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

Why it was recalled

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 .

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.