Biomet Microfixation Recalls Total Temporomandibular Joint Replacement System
Biomet Microfixation is recalling 42 units of the Total Temporomandibular Joint Replacement System because laser etching on the parts is wider and deeper than previously 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, and the source text describes a manufacturing deviation (laser etching dimensions) without reporting any illnesses, injuries, or deaths. This aligns with the rubric for moderate severity involving low-risk contamination or voluntary precautionary recalls where harm is not yet reported.
Plain-English summary
Biomet Microfixation, LLC is recalling 42 units of the Total Temporomandibular Joint Replacement System (Model 24-6650TI, Lot #s: 531960A, 531960B). The recall is due to laser etching on the parts being wider and deeper than the conditions previously validated.
The affected devices were distributed worldwide, including in the United States (Pennsylvania, Minnesota, California) and internationally to Australia, the Netherlands, France, and the United Kingdom. The product is used for the reconstruction of the temporomandibular joint.
Healthcare providers and patients should contact Biomet Microfixation, LLC for instructions on how to return or replace the affected devices. No specific instructions for immediate patient action are provided in the source text beyond the recall notification.
The recalled product
- Product
- Total Temporomandibular Joint Replacement System- 50mm Rt Stand Off 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 (3)
- Model 24-6650TI
- Lot #s: 531960A
- 531960B.
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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