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 validated conditions.
What this means for you
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 may affect device integrity, representing a risk of harm 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 01-6550TI. The recall involves specific lots: 531890A, 531890B, 531900A, 531900B, 544220B, 544230A, 544230B, 544200A, 544200B, 544210A, 544210B, and 544220A.
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 specific devices should contact Biomet Microfixation, LLC for instructions on how to proceed. The U.S. Food and Drug Administration has classified this as a Class II recall.
The recalled product
- Product
- Total Temporomandibular Joint Replacement System- 50mm Rt Narrow Ti Mand 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 (13)
- Model 01-6550TI
- Lot #s: 531890A
- 531890B
- 531900A
- 531900B
- 544220B
- 544230A
- 544230B
- 544200A
- 544200B
- 544210A
- 544210B
- 544220A.
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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