Biomet Microfixation Recalls TMJ Fossa Component Due to Product Mix-Up
Biomet Microfixation is recalling one unit of a TMJ fossa component because a product mix-up occurred before final packaging and labeling.
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 explicitly states that the issue was a product mix-up prior to final packaging and labeling, with no reported illnesses or injuries, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Biomet Microfixation, LLC is recalling one unit of the Biomet Microfixation Temporomandibular Joint (TMJ) Patient Matched Left Fossa, Part #CP751506, Lot #478490. The recall was initiated because a product mix-up occurred prior to the final package and labeling process.
The affected product is a component of the Total Temporomandibular Joint (TMJ) replacement system, which is implanted in the jaw to reconstruct a diseased or damaged temporomandibular joint. The specific unit involved in this recall was distributed to Denmark only.
Consumers and healthcare providers who have this specific part number and lot number should contact Biomet Microfixation, LLC for further instructions. The source text does not report any illnesses or injuries associated with this recall.
The recalled product
- Product
- Biomet Microfixation Temporomandibular Joint (TMJ) Patient Matched Left Fossa Part# CP751506 The Total Temporomandibular Joint (TMJ) replacement system is implanted in the jaw to functionally reconstruct a diseased and/or damaged temporomandibular joint. The Total TMJ replace
- Manufacturer
- Biomet Microfixation, LLC
- Affected units
- 1
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)
- Part #CP751506 Lot #478490
Distribution
Distribution scope not specified by the agency.
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