Zimmer Biomet Recalls Sidus Stem-Free Shoulder Humeral Head Implants
Zimmer Biomet is recalling Sidus Stem-Free Shoulder Humeral Head implants because non-highly polished units may adhere to the LDPE bag.
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 source text does not report any injuries or illnesses, indicating a theoretical or low-risk hazard related to packaging adherence.
Plain-English summary
Zimmer Biomet, Inc. is recalling Sidus Stem-Free Shoulder Humeral Head implants, Item Nos. 0104555380 through 0104555525. The recall covers 5,459,583 total devices that were distributed nationwide. All affected products were manufactured prior to January 2014.
The recall is being conducted because non-highly polished implants may adhere to the LDPE bag, which was the previous packaging configuration. This issue could potentially affect the handling or integrity of the device during storage or preparation.
Healthcare providers and patients who have received these specific implants should contact Zimmer Biomet or their healthcare provider for further instructions. The source text does not report any specific injuries or illnesses associated with this recall.
The recalled product
- Product
- Sidus Stem-Free Shoulder Humeral Head, Item Nos. 0104555380 0104555400 0104555420 0104555440 0104555460 0104555480 0104555485 0104555500 0104555505 0104555520 0104555525
- Manufacturer
- Zimmer Biomet, Inc.
- Hazard
- Affected units
- 5,459,583
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)
- All product manufactured prior to January 2014.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 41 recalled by Zimmer Biomet, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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