FDA-Device2014-12-17Class II
Total Temporomandibular Joint Replacement System- 45mm Lft Stand Off Ti Mand Reconstruction of the temporomandibular joint
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 Stand Off Ti Mand Reconstruction of the temporomandibular joint
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0510-2015Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief