Reported Oct 9, 2019 · Terminated

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

Zimmer GmbH

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Zimmer GmbH · Sulzerallee 8 · Winterthur, N/A · N/A

Is this the product you have?

  • Sidus Stem-Free
  • Shoulder Humeral Head 50-18 Item number01.04555.500
  • orthopedic implant - Product UsageThe 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
Lot codes and dates
  • Lot # 2941696
  • UDI(01) 00889024415973 (17) 280299 (10) 2941696
Amount recalled
19 unit worldwide

Where it was sold

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.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Jul 20, 2020 · Data as of Sep 19, 5:37 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.