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Zimmer GmbH recalls Sidus Stem-Free Shoulder Humeral Head 50-18 Item number: 01.04555.500 orthopedic implant - Product Usage: The Sidus Ste
Recalled October 9, 2019 · FDA recall Z-2762-2019 · Zimmer
Hazard
Incorrect labeling on the products package. The label on the package shows size 50-18 whereas the implant inside the packaging size 40-14. · FDA Class II
Units
19 unit worldwide
Sold at
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.
Description
Incorrect labeling on the products package. The label on the package shows size 50-18 whereas the implant inside the packaging size 40-14.
Product
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.
Manufacturer(s)
Zimmer GmbH
Made in
Switzerland
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →