Biomet 3i, LLC: Medical Device Recall in 2016 - (Recall #: Z-0840-2017)

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 CERTAIN LOW PROFILE ABUTMENT 4.1MM(D) X 2MM(H) 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-0840-2017

Event ID: 75761

Reason for Recall:

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

Status: Terminated

Product Quantity: 108

Code Information:

Part # ILPC442 Lot # 2016030811

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