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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