Medacta Usa Inc recalls Medacta Shoulder SYSTEM HUMERAL ANATOMICAL METAPHYSIS, REF 04.01.0023 through 04.01.0055, all sizes - Product Usage: Th…

Recall date

November 4, 2019

Source

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

Recall number

Z-0775-2020

FDA classification

Class II

Brand / firm

Medacta Usa Inc

Sold / distributed

US Nationwide distribution in the states of KY, NJ, IL, SC, CA, TX, ID, AR, OH.

Why it was recalled

Certain lot numbers of the Medacta Humeral Anatomical Cementless Metaphysis have a dimensional condition that could limit insertion of the screw used to lock the metaphysis to the humeral diaphysis.

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

What was recalled

Medacta Shoulder SYSTEM HUMERAL ANATOMICAL METAPHYSIS, REF 04.01.0023 through 04.01.0055, all sizes - Product Usage: The Medacta Anatomic Shoulder Prosthesis is indicated for treatment of humeral fractures and for primary or revision total shoulder replacement in patients with an intact or reparable rotator cuff shoulder joint, severe arthropathy or a previously failed joint replacement.