Biomet 3i, LLC: Medical Device Recall in 2016 - (Recall #: Z-0861-2017)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

Product Description:

BIOMET 3i LOW PROFILE ABUTMENT NON-HEXED TEMPORARY CYLINDER An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation

Product Classification:

Class II

Date Initiated: September 14, 2016

Date Posted: December 28, 2016

Recall Number: Z-0861-2017

Event ID: 75761

Reason for Recall:

A limited number of product pouches may not have been sealed during packaging.

Status: Terminated

Product Quantity: 1,371

Code Information:

Part # LPCTC2 Lot's # 2015111121, 2015120492, 2015120495, 2015120497, 2015121108, 2015121114, 2015121115, 2016011524, 2016031197, 2016031875, 2016031878, 2016050008, 2016060232, 2016060233, 2016060234, and 2016062347

Distribution Pattern:

Worldwide Distribution to Austria, Belgium, Switzerland, Germany, Spain, France, Great Britain, Ireland, Italy, Lithuania, Portugal and Sweden

Voluntary or Mandated:

Voluntary: Firm initiated