Device product
Biomet 3i Dental Implant, Non-Platform Switched Parallel Walled Implant 5mm (D) x 13mm (L)
Z-1961-2013
Product summary
- Firm
- Biomet 3i, LLC
- Event
- Event 65005
- Status
- Terminated
- Classification
- Class II
- Quantity
- 33
- Official record key
device-enforcement:Z-1961-2013
Official wording
Reason: 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.
Code information: Lot number: 2012101530 Exp 2017/12 Catalog #: BNSS513
Distribution pattern: Distribution to the state of Massachusetts, and the foreign countries of Australia, Belgium, Spain, Denmark, France, Luxembourg, Switzerland, Germany, Bonaire, Sweden, and Italy.
Derived failure modes
-
Labeling or packaging
mislabeled