FDA-Device2014-09-10Class II
Biomet Microfixation Temporomandibular Joint (TMJ) Patient Matched Left Fossa Part# CP751506 The Total Temporomandibular Joint (TMJ) replacement system is implanted in the jaw to functionally reconstruct a diseased and/or damaged temporomandibular joint. The Total TMJ replacement system is a two-component system comprised of mandibular condyle and a glenoid fossa components. Both components are available in multiple stock sizes as right and left specific designs and are attached to the bones
Biomet Microfixation, LLC
Hazard
Product mix occurred prior to final package and labeling process.
Sold states
Worldwide Distribution to Denmark only.
Affected count
1
Manufactured in
1520 Tradeport Dr, Jacksonville, FL, United States
Products
Biomet Microfixation Temporomandibular Joint (TMJ) Patient Matched Left Fossa Part# CP751506 The Total Temporomandibular Joint (TMJ) replacement system is implanted in the jaw to functionally reconstruct a diseased and/or damaged temporomandibular joint. The Total TMJ replacement system is a two-component system comprised of mandibular condyle and a glenoid fossa components. Both components are available in multiple stock sizes as right and left specific designs and are attached to the bones by screws.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2566-2014Don't want to check this manually?
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