PlainRecalls
FDA Devices Moderate Class II Terminated

BIOMET 3i LOW PROFILE 17¿ 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

Reported: December 28, 2016 Initiated: September 14, 2016 #Z-0846-2017

Product Description

BIOMET 3i LOW PROFILE 17¿ 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

Reason for Recall

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

Details

Recalling Firm
Biomet 3i, LLC
Units Affected
246
Distribution
Worldwide Distribution to Austria, Belgium, Switzerland, Germany, Spain, France, Great Britain, Ireland, Italy, Lithuania, Portugal and Sweden
Location
Palm Beach Gardens, FL

Frequently Asked Questions

What product was recalled?
BIOMET 3i LOW PROFILE 17¿ 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. Recalled by Biomet 3i, LLC. Units affected: 246.
Why was this product recalled?
A limited number of product pouches may not have been sealed during packaging.
Which agency issued this recall?
This recall was issued by the FDA Devices on December 28, 2016. Severity: Moderate. Recall number: Z-0846-2017.