Biomet Microfixation, LLC Total Temporomandibular Joint Replacement System- 45mm Lft Narrow Ti Mand Recall
Class II: 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
Class II recall indicates potential for temporary health effects.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Total Temporomandibular Joint Replacement System- 45mm Lft Narrow Ti Mand
Brand
Biomet Microfixation, LLC
Lot Codes / Batch Numbers
Model 01-6546TI, Lot #s: 531880B, 535890B, 531870A, 531870B, 531880A, 535890D, 535890A, 535890C.
Products Sold
Model 01-6546TI, Lot #s: 531880B, 535890B, 531870A, 531870B, 531880A, 535890D, 535890A, 535890C.
Biomet Microfixation, LLC is recalling Total Temporomandibular Joint Replacement System- 45mm Lft Narrow Ti Mand due to Laser etching on the parts is wider and deeper than the conditions previously validated.. This is a Class I recall, indicating a high risk of serious health consequences or death. Based on FDA medical device enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Laser etching on the parts is wider and deeper than the conditions previously validated.
Recommended Action
Per FDA guidance
Healthcare providers and patients should stop using the device and contact the manufacturer for further instructions. Report problems to FDA MedWatch.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
CA, MN, PA
Page updated: Jan 10, 2026