Biomet Microfixation Recalls Total Temporomandibular Joint Replacement Systems
Biomet Microfixation is recalling 42 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, but the source text does not report any hospitalizations, injuries, or illnesses, and the defect is a manufacturing deviation (laser etching) rather than a high-risk pathogen or structural failure causing immediate harm.
Plain-English summary
Biomet Microfixation, LLC is recalling 42 units of the Total Temporomandibular Joint Replacement System (Model 24-6651TI). The affected lots are 472560A, 472560B, 472570A, 518520A, 518520B, and 472570B. 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, and California) and internationally to Australia, the Netherlands, France, and the United Kingdom. The source text does not specify the number of patients affected or report any illnesses or injuries associated with the use of these devices.
Healthcare providers and patients should contact Biomet Microfixation, LLC for instructions on how to return the affected devices or obtain replacements. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- Total Temporomandibular Joint Replacement System- 50mm 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 (7)
- Model 24-6651TI
- Lot #s: 472560A
- 472560B
- 472570A
- 518520A
- 518520B
- 472570B.
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
Same manufacturer · Biomet Microfixation, LLC
See all →- ModerateBiomet Microfixation Recalls Surgical Trays Due to Part Number Mismatch
FDA (Devices) · 2017-05-24
- HighBiomet Microfixation Recalls Hard Tissue Replacement Implants Due to Sterility Deficiency
FDA (Devices) · 2016-09-14
- ModerateBiomet Thinflap System Cases Recalled Due to Lid Opening Difficulty
FDA (Devices) · 2015-10-28
- ModerateBiomet Neuro Combo Set Case Lid Requiring Excessive Force Recalled
FDA (Devices) · 2015-10-28
- ModerateBiomet Microfixation Recalls Total Temporomandibular Joint Replacement Systems
FDA (Devices) · 2014-12-17
Same hazard · manufacturing defect
See all →- HighBeak & Skiff Alcohol Antiseptic Sanitizer recalled for acetaldehyde contamination
FDA (Drugs) · 2026-09-02
- HighSun Pharmaceutical Recalls Carbamazepine Tablets Due to Manufacturing Deviations
FDA (Drugs) · 2026-08-26
- HighUSTAR II Knee System Hinge Box Trial Recall
FDA (Devices) · 2026-08-12
- HighU2 Total Knee System Femoral Valgus Adaptor Recall
FDA (Devices) · 2026-08-12
- HighUnited Orthopedic Corp. Recalls Femoral Valgus Offset Adaptors for U2 Total Knee System
FDA (Devices) · 2026-08-12