Zimmer Sidus Stem-Free Shoulder Humeral Head Recall for Incorrect Labeling
Zimmer GmbH is recalling 19 Sidus Stem-Free Shoulder Humeral Head implants due to incorrect size labeling on the packaging.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard is a minor labeling error where the package size does not match the implant size, fitting the 'Moderate' criteria for minor labeling errors.
Plain-English summary
Zimmer GmbH is recalling 19 units of the Sidus Stem-Free Shoulder Humeral Head 50-18 (Item number: 01.04555.500) orthopedic implant. The recall is due to incorrect labeling on the product package, which displays size 50-18 while the implant inside is actually size 40-14.
The affected products were distributed worldwide, including in the United States (Alabama, Colorado, Kansas, New Jersey, New York, Ohio, and Oklahoma) and in Belgium, the Czech Republic, France, Germany, Switzerland, and the United Kingdom. The specific lot number is 2941696.
Healthcare providers should stop using the affected implants and contact Zimmer GmbH for further instructions. Patients who have already received the implant should contact their healthcare provider to discuss the labeling discrepancy.
The recalled product
- 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 gle
- Manufacturer
- Zimmer GmbH
- Hazard
- Affected units
- 19
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot # 2941696 UDI: (01) 00889024415973 (17) 280299 (10) 2941696
Distribution
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