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Biomet 3i, LLC recalls Biomet 3i Dental Implant, Non-Platform Switched Parallel Walled Implant 5mm (D) x 13mm (L)
Recalled August 21, 2013 · FDA recall Z-1961-2013 · Biomet 3i
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. · FDA Class II
Units
33
Sold at
Distribution to the state of Massachusetts, and the foreign countries of Australia, Belgium, Spain, Denmark, France, Luxembourg, Switzerland, Germany, Bonaire, Sweden, and Italy.
Description
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.
Product
Biomet 3i Dental Implant, Non-Platform Switched Parallel Walled Implant 5mm (D) x 13mm (L)
Manufacturer(s)
Biomet 3i, LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →