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 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 Dental Implant Abutments Recalled for Packaging Seal Defects
Biomet 3i is recalling 228 dental implant abutments because a limited number of product pouches may not have been sealed during packaging.
Product
BIOMET 3i CERTAIN LOW PROFILE 30¿ ABUTMENT 4.1MM(D) X 5MM(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 101 units of a specific dental implant abutment because some product pouches may not have been sealed during packaging.
Product
BIOMET 3i CERTAIN LOW PROFILE ONE-PIECE ABUTMENT 3.4MM(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 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 Abutments Recalled for Packaging Seal Defects
Biomet 3i is recalling 27 specific dental implant abutments because some product pouches may not have been sealed during packaging.
Product
BIOMET 3i CERTAIN LOW PROFILE 30¿ ABUTMENT 3.4MM(D) X 5MM(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 216 dental implant abutments because some product pouches may not have been sealed during packaging.
Product
BIOMET 3i LOW PROFILE 17¿ 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
LowFDA (Devices)··2016-12-28
Biomet 3i Dental Abutments Recalled for Potential Packaging Seal Defects
Biomet 3i is recalling 46 units of a specific dental implant abutment because some product pouches may not have been sealed during packaging.
Product
BIOMET 3i CERTAIN LOW PROFILE ONE-PIECE ABUTMENT 4.1MM(D) X 3MM(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 a limited number of Low Profile 30-degree abutments because some product pouches may not have been sealed during packaging.
Product
BIOMET 3i LOW PROFILE 30¿ ABUTMENT 3.4MM(D) X 5MM(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 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
LowFDA (Devices)··2016-12-28
Biomet 3i Low Profile Dental Implant Abutments Recalled for Packaging Defect
Biomet 3i is recalling 50 units of Low Profile Dental Implant Abutments because some product pouches may not have been sealed during packaging.
Product
BIOMET 3i CERTAIN LOW PROFILE ABUTMENT 3.4MM(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