Zimmer Biomet Recalls Metasul Femoral Heads Due to Packaging Adhesion
Zimmer Biomet is recalling Metasul Femoral Heads because non-highly polished implants may adhere to the LDPE bag 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, but the source text does not report any hospitalizations, injuries, or illnesses, aligning with the 'Moderate' criteria for minor issues or voluntary precautionary recalls without reported harm.
Plain-English summary
Zimmer Biomet, Inc. is recalling Metasul Femoral Heads, various sizes, Item Nos. 00877004001 through 00877004005. The recall involves 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 is classified as an FDA Class II recall.
Healthcare providers and patients should contact Zimmer Biomet for instructions on how to handle the recalled devices.
The recalled product
- Product
- Metasul Femoral Heads, various sizes, Item Nos. 00877004001 00877004002 00877004003 00877004004 00877004005
- 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 products 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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