Sidus Stem-Free Shoulder Humeral Head 50-18 recalled over labeling errors

Recall date

August 21, 2019

Source

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

Official notice title

Zimmer GmbH recalls Sidus Stem-Free Shoulder Humeral Head 50-18 Item number: 01.04555.500 orthopedic implant - Product Usage: The Sidus Ste…

Recall number

Z-2762-2019

FDA classification

Class II

Brand / firm

Zimmer GmbH

Sold / distributed

Worldwide distribution - iUS Nationwide distribution including states of AL, CO, KS, NJ, NY, OH, and OK, and countries of Belgium, Czech Republic, France, Germany, Switzerland, and United Kingdom.

Why it was recalled

Incorrect labeling on the products package. The label on the package shows size 50-18 whereas the implant inside the packaging size 40-14.

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

What was recalled

Sidus Stem-Free Shoulder Humeral Head 50-18 Item number: 01.04555.500 orthopedic implant - Product Usage: The Sidus Stem-Free Shoulder is designed for long-term implantation into the human shoulder joint as a total shoulder arthroplasty in combination with Zimmer or Biomet s glenoid components, or as a hemi shoulder arthroplasty.