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 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 hospitalizations, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Biomet Microfixation, LLC is recalling 42 units of the Total Temporomandibular Joint Replacement System, specifically the 45mm Rt Standard TI Mand model (Model 24-6545TI). The affected lots are 520220B, 520220A, 520210A, and 520210B. The recall was initiated because the laser etching on the parts is 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. This recall is classified as Class II by the U.S. Food and Drug Administration.
Healthcare providers and patients should contact Biomet Microfixation, LLC for instructions on how to return or replace the affected devices. Patients who have had these implants should consult their healthcare provider regarding the recall and any necessary follow-up care.
The recalled product
- Product
- Total Temporomandibular Joint Replacement System- 45mm Rt Standard 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 (5)
- Model 24-6545TI
- Lot #s: 520220B
- 520220A
- 520210A
- 520210B
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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