Biomet 3i, LLC: Medical Device Recall in 2013 - (Recall #: Z-1961-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

Product Description:

Biomet 3i Dental Implant, Non-Platform Switched Parallel Walled Implant 5mm (D) x 13mm (L)

Product Classification:

Class II

Date Initiated: May 10, 2013

Date Posted: August 21, 2013

Recall Number: Z-1961-2013

Event ID: 65005

Reason for Recall:

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.

Status: Terminated

Product Quantity: 33

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.

Voluntary or Mandated:

Voluntary: Firm initiated