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 a
Check against the official notice below — it lists the full affected range.
Zimmer GmbH is recalling 19 units of the Sidus Stem-Free Shoulder Humeral Head 50-18 orthopedic implant due to incorrect labeling on the product package. The package label indicates the implant size is 50-18, but the actual implant inside is size 40-14. The affected products are from Lot #2941696 and were distributed worldwide, including in the United States (Alabama, Colorado, Kansas, New Jersey, New York, Ohio, and Oklahoma) and internationally (Belgium, Czech Republic, France, Germany, Switzerland, and the United Kingdom).
The size mismatch between the package label and the actual implant could result in the wrong size being used during surgery. The recall source does not specify what action affected consumers should take.
Written by software from the official notice below. Not reviewed by a lawyer.
Incorrect labeling on the products package. The label on the package shows size 50-18 whereas the implant inside the packaging size 40-14.
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. Quantity: 19 unit worldwide Lot/code info: Lot # 2941696 UDI: (01) 00889024415973 (17) 280299 (10) 2941696
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.