FDA (Devices) recall action 75761

Biomet 3i, LLC recalled 36 products on 2016-12-28

The FDA (Devices) publishes a recall like this one as 36 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 36 pages.

Products: 36
Announced: 2016-12-28
Critical: 0
Units: 9,363

Why these products were recalled

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

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

26–36 of 36

ModerateFDA (Devices)··2016-12-28
Biomet 3i Dental Implant Abutments Recalled for Packaging Seal Defects
Biomet 3i, LLC is recalling 160 units of Low Profile Abutments because some product pouches may not have been sealed during packaging.
Product
BIOMET 3i LOW PROFILE ABUTMENT 4.1MM(D) X 1MM(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
Category
Distribution
0 states
ModerateFDA (Devices)··2016-12-28
Biomet 3i Low Profile Abutment Titanium Retaining Screw Recall
Biomet 3i is recalling 1,633 Low Profile Abutment Titanium Retaining Screws because a limited number of product pouches may not have been sealed during packaging.
Product
BIOMET 3i LOW PROFILE ABUTMENT TITANIUM RETAINING SCREW 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
Category
Distribution
0 states
LowFDA (Devices)··2016-12-28
Biomet 3i Low Profile Dental Abutment Recall for Packaging Seal Defects
Biomet 3i is recalling 108 dental implant abutments because some product pouches may not have been sealed during packaging.
Product
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
Category
Distribution
0 states
LowFDA (Devices)··2016-12-28
Biomet 3i Dental Implant Abutments Recalled for Packaging Seal Defects
Biomet 3i is recalling 137 dental implant abutments because some product pouches may not have been sealed during packaging.
Product
BIOMET 3i LOW PROFILE ONE-PIECE 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
Category
Distribution
0 states
ModerateFDA (Devices)··2016-12-28
Biomet 3i Dental Implant Abutments Recalled for Packaging Seal Defects
Biomet 3i is recalling 108 dental implant abutments because some product pouches may not have been sealed during packaging.
Product
BIOMET 3i CERTAIN LOW PROFILE ONE-PIECE ABUTMENT 4.1MM(D) X 4MM(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
Category
Distribution
0 states
ModerateFDA (Devices)··2016-12-28
Biomet 3i Dental Implant Abutments Recalled for Unsealed Packaging
Biomet 3i is recalling 270 low-profile dental implant abutments because some pouches may not have been sealed during packaging.
Product
BIOMET 3i LOW PROFILE ABUTMENT NON-HEXED PREFORMANCE 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
Category
Distribution
0 states
LowFDA (Devices)··2016-12-28
Biomet 3i Dental Implant Abutments Recalled for Packaging Seal Defects
Biomet 3i is recalling 124 dental implant abutments because some product pouches may not have been sealed during packaging.
Product
BIOMET 3i LOW PROFILE ONE-PIECE ABUTMENT 4.1MM(D) X 4MM(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
Category
Distribution
0 states
ModerateFDA (Devices)··2016-12-28
Biomet 3i Low Profile Dental Implant Abutments Recalled for Packaging Defect
Biomet 3i is recalling 53 units of Low Profile 17° Abutments because some pouches may not have been sealed during packaging.
Product
BIOMET 3i CERTAIN LOW PROFILE 17¿ ABUTMENT 3.4MM(D) X 4MM(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
Category
Distribution
0 states
LowFDA (Devices)··2016-12-28
Biomet 3i Dental Implant Abutment Recall for Packaging Seal Defects
Biomet 3i is recalling 28 dental implant abutments because some product pouches may not have been sealed during packaging.
Product
BIOMET 3i LOW PROFILE ABUTMENT (HEXED) PICK-UP IMPRESSION COPING 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
Category
Distribution
0 states
LowFDA (Devices)··2016-12-28
Biomet 3i Low Profile Abutment Healing Caps Recalled for Packaging Defects
Biomet 3i is recalling 391 Low Profile Abutment Healing Caps because a limited number of product pouches may not have been sealed during packaging.
Product
BIOMET 3i LOW PROFILE ABUTMENT HEALING CAP 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
Category
Distribution
0 states
ModerateFDA (Devices)··2016-12-28
Biomet 3i Low Profile Abutment Quickbridge Recall for Unsealed Pouches
Biomet 3i is recalling 60 units of Low Profile Abutment Quickbridge because some product pouches may not have been sealed during packaging.
Product
BIOMET 3i LOW PROFILE ABUTMENT QUICKBRIDGE 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
Category
Distribution
0 states