FDAFDA · Food and drugs·Recall number Z-1960-2013
Biomet 3i Dental Implant, Parallel Walled 6mm (D) x 10mm (L)
Published August 21, 2013 · Recall initiated: May 10, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Biomet 3i, LLC
- Distributor
- Distribution to the state of Massachusetts, and the foreign countries of Australia, Belgium, Spain, Denmark, France, Luxembourg, Switzerland, Germany, Bonaire, Sweden, and Italy.
- Lot
- Lot number: 2012111613 Exp 2017/12 Catalog #: BOPS6510
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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