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.
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. The hazard involves a manufacturing deviation (laser etching dimensions) without reported injuries or illnesses, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Biomet Microfixation, LLC is recalling 42 units of the Total Temporomandibular Joint Replacement System (Model 24-6646TI). The recall involves specific lots: 526000A, 526000B, 526010B, 526010A, 535390A, 535390B, 535390C, 535390D, 538720A, 538720B, 538720C, and 538720D.
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.
Healthcare providers and patients who have received these devices should contact Biomet Microfixation, LLC for instructions on how to proceed. 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 Lft 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 (13)
- Models 24-6646TI
- Lot #s: 526000A
- 526000B
- 526010B
- 526010A
- 535390A
- 535390B
- 535390C
- 535390D
- 538720A
- 538720B
- 538720C
- 538720D
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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