—#170578

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.

FDA product code: PHX — Shoulder Prosthesis, Reverse Configuration
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K162726
Affected lot / code info: Catalog Number: 300-30-08; UDI: 10885862515766; Serial Numbers: 5569566, 5569576, 5569579, 5569582, 5569584, 5569586, 5569589, 5569595.

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 .

Root cause (FDA determination)

Packaging

Action the firm took

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.

Recalling firm

Firm: Exactech, Inc.
Address: 2320 NW 66th Ct, Gainesville, Florida 32653-1630

Distribution

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

Timeline

Recall initiated: 2018-12-05
Terminated: 2021-04-29
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #170578. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.