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
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 source text describes a manufacturing deviation (laser etching dimensions) without reporting any illnesses, injuries, or deaths, 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 24-6650TI. The recall involves specific lots of the 50mm Rt Standard Ti Mand reconstruction component used for temporomandibular joint reconstruction.
The recall was initiated because the laser etching on the parts is wider and deeper than the conditions previously validated. The affected products 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 implants should contact Biomet Microfixation, LLC for further instructions on how to proceed. The recall number is Z-0517-2015.
The recalled product
- Product
- Total Temporomandibular Joint Replacement System- 50mm Rt Standard Ti Mand Reconstruction of the temporomandibular joint
- Manufacturer
- Biomet Microfixation, LLC
- Category
- Medical Device — Implant
- 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 (20)
- Model 24-6650TI
- Lot #s: 518480B
- 518480A
- 525970A
- 525970B
- 525980B
- 518490A
- 526070A
- 525990A
- 525990B
- 526060A
- 526060B
- 526070B
- 525980A
- 550330A
- 550330B
- 550340A
- 550340B
- 550350A
- 550360A
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.
See all 14 products in this recall →Related recalls
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