FDA-Device2013-08-21Class II
Biomet 3i Dental Implant, Parallel Walled 6mm (D) x 10mm (L)
Biomet 3i, LLC
Hazard
A small number of outer implant boxes may be mislabeled. The inner tray, containing the implant, is label correctly. This condition, if present and not recognized could potentially result in the dental implant not being able to be placed into the osteotomy or seated to the desired depth if placement is attempted.
Sold states
Distribution to the state of Massachusetts, and the foreign countries of Australia, Belgium, Spain, Denmark, France, Luxembourg, Switzerland, Germany, Bonaire, Sweden, and Italy.
Affected count
51
Manufactured in
4555 Riverside Dr, Palm Beach Gardens, FL, United States
Products
Biomet 3i Dental Implant, Parallel Walled 6mm (D) x 10mm (L)
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1960-2013Don't want to check this manually?
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