Zimmer GmbH: Medical Device Recall in 2019 - (Recall #: Z-2762-2019)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2019.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: August 21, 2019

Date Posted: October 9, 2019

Recall Number: Z-2762-2019

Event ID: 83689

Reason for Recall:

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

Status: Terminated

Product Quantity: 19 unit worldwide

Code Information:

Lot # 2941696 UDI: (01) 00889024415973 (17) 280299 (10) 2941696

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated