Biomet Microfixation Recalls Surgical Trays Due to Part Number Mismatch
Biomet Microfixation is recalling 33 TraumaOne System Surgical Trays because the part number on the lid differs from the base.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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 describes a labeling discrepancy (part number mismatch) without reporting any illnesses or injuries, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Biomet Microfixation, LLC is recalling 33 units of the TraumaOne System Surgical Tray, Model # 46-1600. The recall was initiated because part of the number on the tray lid differs from the part number on the base.
The affected units include specific part and lot numbers: Part Number 46-1610 (Lot Numbers 709730 and 709740) and Part Number 46-1620 (Lot Numbers 709710 and 709720). These products were distributed to locations in Alabama, Missouri, and Utah, as well as Canada, Australia, the Netherlands, and Egypt.
This is a Class II recall, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences. The source text does not report any illnesses or injuries associated with this defect.
The recalled product
- Product
- Biomet Microfixation TraumaOne System Surgical Tray - Model # 46-1600
- Manufacturer
- Biomet Microfixation, LLC
- Hazard
- Affected units
- 33
Distribution
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