Biomet Microfixation Recalls Total Temporomandibular Joint Replacement Systems
Biomet Microfixation is recalling 42 units of 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, which typically corresponds to a moderate severity where the probability of serious adverse health consequences is remote or the consequences are temporary/medically reversible. No specific injuries or illnesses are reported in the source text.
Plain-English summary
Biomet Microfixation, LLC is recalling 42 units of the Total Temporomandibular Joint Replacement System- 45mm Lft Narrow Ti Mand. The recall is due to laser etching on the parts being wider and deeper than the conditions previously validated.
The affected products are Model 01-6546TI with lot numbers 531880B, 535890B, 531870A, 531870B, 531880A, 535890D, 535890A, and 535890C. These units were distributed worldwide, including in the United States (Pennsylvania, Minnesota, California) and internationally to Australia, the Netherlands, France, and the United Kingdom.
This is a Class II recall, meaning there is a reasonable probability that the use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences or that the probability of serious adverse health consequences is remote. Consumers and healthcare providers should contact Biomet Microfixation, LLC for instructions on how to return or replace the affected devices.
The recalled product
- Product
- Total Temporomandibular Joint Replacement System- 45mm Lft Narrow Ti Mand
- 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 01-6546TI
- Lot #s: 531880B
- 535890B
- 531870A
- 531870B
- 531880A
- 535890D
- 535890A
- 535890C.
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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