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Recall Observatory FDA recall evidence

Device product

Biomet 3i Dental Implant, Parallel Walled 6mm (D) x 10mm (L)

Z-1960-2013

May 10, 2013

Class II

Product summary

Firm
Biomet 3i, LLC
Event
Event 65005
Status
Terminated
Classification
Class II
Quantity
51
Official record key
device-enforcement:Z-1960-2013

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: 2012111613 Exp 2017/12 Catalog #: BOPS6510

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

    reason.labeling_packaging · v1.0.0

    mislabeled