FDA-Device2014-12-17Class II
Total Temporomandibular Joint Replacement System- 45mm Lft Narrow Ti Mand
Biomet Microfixation, LLC
Hazard
Laser etching on the parts is wider and deeper than the conditions previously validated.
Sold states
Worldwide Distribution - USA including PA, MN, CA and Internationally to Australia, Netherlands, France, and United Kingdom.
Affected count
42
Manufactured in
1520 Tradeport Dr, N/A, Jacksonville, FL, United States
Products
Total Temporomandibular Joint Replacement System- 45mm Lft Narrow Ti Mand
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0509-2015Don't want to check this manually?
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