FDA recall Z-2762-2019

Zimmer GmbH · Class II · device

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.

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

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.

Key facts

Status: Terminated
Initiation date: 2019-08-21
Report date: 2019-10-09
Termination date: 2020-07-20
Voluntary/Mandated: Voluntary: Firm initiated
Location: Winterthur, N/A, Switzerland

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2762-2019