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 validated conditions.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a manufacturing deviation (laser etching) that could affect the safety of a medical device, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Biomet Microfixation, LLC is recalling 42 units of the Total Temporomandibular Joint Replacement System, Model 24-6551TI. The recall involves specific lot numbers: 544160A, 525190A, 525190B, 525180B, 544170A, 544180B, 544160B, 525180A, and 544180A.
The reason for the recall is that the laser etching on the parts is wider and deeper than the conditions previously validated. The FDA has classified this as a Class II recall.
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 should contact Biomet Microfixation, LLC for further instructions on how to proceed with the recall.
The recalled product
- Product
- Total Temporomandibular Joint Replacement System- 50mm Lft Standard Ti Mandi Reconstruction of the temporomandibular joint
- Manufacturer
- Biomet Microfixation, LLC
- 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 (10)
- Model 24-6551TI
- Lot #s: 544160A
- 525190A
- 525190B
- 525180B
- 544170A
- 544180B
- 544160B
- 525180A
- 544180A.
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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