Z-2762-2019 Class II Terminated

Recalled by Zimmer GmbH — Winterthur, N/A

Recall Details

Product Type
Devices
Report Date
October 9, 2019
Initiation Date
August 21, 2019
Termination Date
July 20, 2020
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
19 unit worldwide

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.

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.

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.

Code Information

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