Biomet Microfixation Recalls Total Temporomandibular Joint Replacement Systems
Biomet Microfixation is recalling 42 Total Temporomandibular Joint Replacement Systems because laser etching on the parts is wider and deeper than validated conditions.
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. The hazard is a manufacturing deviation (laser etching) without reported adverse health consequences, fitting the criteria for a moderate severity score.
Plain-English summary
Biomet Microfixation, LLC is recalling 42 units of the Total Temporomandibular Joint Replacement System (Model 01-6545TI). The recall is due to laser etching on the parts being wider and deeper than the conditions previously validated.
The affected products were distributed worldwide, including in the United States (Pennsylvania, Minnesota, California) and internationally to Australia, the Netherlands, France, and the United Kingdom. The specific lot numbers involved are 535380D, 531850A, 531850B, 531860A, 531860B, 535380B, 535380C, and 535380A.
Healthcare providers and patients should contact Biomet Microfixation for instructions on how to handle the recalled devices. The source text does not report any specific injuries or illnesses associated with this recall.
The recalled product
- Product
- Total Temporomandibular Joint Replacement System- 45mm Rt Narrow Ti Mand Reconstruction of the temporomandibular joint
- Manufacturer
- Biomet Microfixation, LLC
- Hazard
- Affected units
- 42
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 (9)
- Model 01-6545TI
- Lot #s: 535380D
- 531850A
- 531850B
- 531860A
- 531860B
- 535380B
- 535380C
- 535380A.
Distribution
Part of a larger recall action
This product is one of 14 recalled by Biomet Microfixation, LLC 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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