Biomet, Inc. recalls Biomet Comprehensive Reverse Shoulder Glenosphere Mini Baseplate With Taper Adapter-indicated for primary, fracture, or…

Recall date

February 25, 2020

Source

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

Recall number

Z-1615-2020

FDA classification

Class II

Brand / firm

Biomet, Inc.

Sold / distributed

International distribution - country of Netherland.s

Why it was recalled

Package is intended to contain one (1) baseplate and one (1) taper adapter; however, devices may be packaged with two (2) baseplates and no (0) adapters.

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

What was recalled

Biomet Comprehensive Reverse Shoulder Glenosphere Mini Baseplate With Taper Adapter-indicated for primary, fracture, or revision total shoulder replacement for the relief of pain and significant disability due to gross rotator cuff deficiency Item Number: 010000589