Biomet 3i Recalls
222 recalls on record · June 27, 2012 to October 14, 2020 · Medical Devices
Recalls by year
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20
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
August 24, 2016Medical DevicesFDA
Biomet 3i, LLC recalls Certain Straight Healing Abutment 4.1mm(D) x 4.1mm(P) x 4mm(H) Item:ISHA44 Dental implants
Hazard: Pouches may not have been sealed during packing.
August 24, 2016Medical DevicesFDA
Biomet 3i, LLC recalls Certain Pick-Up Coping 5mm(D) x 5mm(P) Item:IWIP55 Dental implants
Hazard: Pouches may not have been sealed during packing.
August 24, 2016Medical DevicesFDA
Biomet 3i, LLC recalls Certain Pick-Up Coping 4.1mm(D) x 5mm(P) Item: IIIC12 Dental implants
Hazard: Pouches may not have been sealed during packing.
August 24, 2016Medical DevicesFDA
Biomet 3i, LLC recalls Certain Pick-Up Coping 4.1mm(D) x 4.1mm(P) Item: IIIC41 Dental implants
Hazard: Pouches may not have been sealed during packing.
August 24, 2016Medical DevicesFDA
Biomet 3i, LLC recalls Certain Gingihue Post 4.1mm(D) x 5mm(P) x 4mm(H) Item: IAPP454G Dental implants
Hazard: Pouches may not have been sealed during packing.
August 24, 2016Medical DevicesFDA
Biomet 3i, LLC recalls Certain Gingihue Post 3.4mm(D) x 3.8mm(P) x 2mm(H) Item: IMAP32G Dental implants
Hazard: Pouches may not have been sealed during packing.
August 24, 2016Medical DevicesFDA
Biomet 3i, LLC recalls Certain Gingihue Post 5mm(D) x 5mm(P) x 2mm(H) Item: IWPP552G Dental implants
Hazard: Pouches may not have been sealed during packing.
August 24, 2016Medical DevicesFDA
Biomet 3i, LLC recalls Certain Gingihue 15 degree Angled Post 4.1mm(D) x 5mm(P) x 4mm(H) Item: IPAP454G. Dental implants
Hazard: Pouches may not have been sealed during packing.
August 24, 2016Medical DevicesFDA
Biomet 3i, LLC recalls Certain Gingihue TM 15 degree Angled Post 3.4mm(D) x 3.8mm(P) x 2mm(H) Item: IMPAP32G Dental implants
Hazard: Pouches may not have been sealed during packing.
August 24, 2016Medical DevicesFDA
Biomet 3i, LLC recalls Certain EP Healing Abutment 5mm(D) x 6mm(P) x 4mm(H) Item: IWTH564 Dental implants
Hazard: Pouches may not have been sealed during packing.
August 24, 2016Medical DevicesFDA
Biomet 3i, LLC recalls Certain EP Healing Abutment 5mm(D) x 5.6mm(P) x 4mm(H) Item: IWTH54 Dental implants
Hazard: Pouches may not have been sealed during packing.
August 24, 2016Medical DevicesFDA
Biomet 3i, LLC recalls Certain EP Healing Abutment 5mm(D) x 5.6mm(P) x 2mm(H) Item: IWTH52 Dental implants
Hazard: Pouches may not have been sealed during packing.
January 13, 2016Medical DevicesFDA
Biomet 3i, LLC recalls BIOMET 3i, PROVIDE IMPRESSION COPING KITS, Catalog # PRK484, PRK485, PRK654, and PRK655 BIOMET 3i Restorative Produc
Hazard: Inadequate biocompatibility testing.
January 13, 2016Medical DevicesFDA
Biomet 3i, LLC recalls BIOMET 3i, PROVIDE IMPRESSION COPINGS, Catalog # PIC484, PIC484H, PIC485, PIC485H, PIC654, PIC654H, PIC655, and PIC655H
Hazard: Inadequate biocompatibility testing.
January 13, 2016Medical DevicesFDA
Biomet 3i, LLC recalls BIOMET 3i, PROVIDE PROTECTION CAP KITS, Catalog # PAK4140, PAK4155, PAK4240, PAK4255, PAK4340, PAK4355, PAK4440, PAK4455
Hazard: Inadequate biocompatibility testing.
January 13, 2016Medical DevicesFDA
Biomet 3i, LLC recalls BIOMET 3i, PROVIDE PROTECTION CAP, Catalog # PPC484, PPC485, PPC654, and PPC655 BIOMET 3i Restorative Products are in
Hazard: Inadequate biocompatibility testing.
January 6, 2016Medical DevicesFDA
Biomet 3i, LLC recalls Radiographic Transparency for Certain and External Connection Tapered Implants. Images that assist with measurements fo
Hazard: Images contained within radiographic transparency ART 1036 are undersized.
November 18, 2015Medical DevicesFDA
Biomet 3i, LLC recalls Biomet 3i Narrow Right Angle Square Driver Tip. Driver tips are attached to a surgical drilling unit to carry component
Hazard: RASQ3N, a square, abutment screw driver tip has been labeled and distributed as RASH3N, a hexed, abutment screw driver tip. Additionally, the RASQ3N received the RASH3N's laser marking "RASH3N" during manufacturing.
November 18, 2015Medical DevicesFDA
Biomet 3i, LLC recalls Biomet 3i Narrow Right Angle Large Driver Tip (Hexed). Driver tips are attached to a surgical drilling unit to carry co
Hazard: The RASH3N, a hexed, abutment screw driver tip has been labeled and distributed as RASQ3N, a square, abutment screw driver tip. Additionally, the RASQ3N received the RASH3N's laser marking "RASH3N" during manufacturing.
September 23, 2015Medical DevicesFDA
Biomet 3i, LLC recalls UCLA Abutment Hexed Castable Cylinder 3.4mm Are accessories to endosseous dental implant to support a prosthetic device
Hazard: MUCC2, non-hexed, castable abutment cylinders, has been labeled and distributed as a MUCC1C, hexed, castable abutment cylinders for this one lot only.
April 22, 2015Medical DevicesFDA
Biomet 3i, LLC recalls OSSEOTITE Certain 2 Implant Rx only; 3.25 x 8.5 - 18 mm. Dental Implants.
Hazard: Endosseous Dental Implants in contact with a residual machine fluid caused the implants to be discolored.
April 22, 2015Medical DevicesFDA
Biomet 3i, LLC recalls OSSEOTITE Tapered Certain Implant Rx Only; 3.25 x 18.5 - 15.0 mm. Dental Implants.
Hazard: Endosseous Dental Implants in contact with a residual machine fluid caused the implants to be discolored.
April 22, 2015Medical DevicesFDA
Biomet 3i, LLC recalls 3i T3 Non-Platform Switched Tapered Implant Rx Only; 3.25 x 8.5 - 15.0 mm Dental Implants.
Hazard: Endosseous Dental Implants in contact with a residual machine fluid caused the implants to be discolored.
September 17, 2014Medical DevicesFDA
Biomet 3i, LLC recalls BIOMET 3i Certain Bellatek Encode Healing Abutment Biomet 3i Healing abutments are temporary abutments indicated for
Hazard: Identifiers on the label are correct but the label has the incorrect color coding.
April 23, 2014Medical DevicesFDA
Biomet 3i, LLC recalls BIOMET 3i Endosseous Dental Implant.
Hazard: Due to residual machining fluid identified by discoloration (darker in appearance) on the external dental implant surface.
March 26, 2014Medical DevicesFDA
Biomet 3i, LLC recalls ENDOBON XENOGRAFT GRANULES 0.5 ML (Bovine bone substitute) Endobon is a bone substitute of bovine origin formed from
Hazard: Individual pieces of a batch of Biomet's Endobon Xenograft Granules 0.5 ML (Bovine Bone substitute) may have an incorrect label with the wrong batch number.
March 26, 2014Medical DevicesFDA
Biomet 3i, LLC recalls Dental Abutment labeled in part: "4555 Riverside Drive Palm Beach Gardens, FL 33410 USA 1-800-342-5454***EDAZ , EDAZx a
Hazard: Reports relating to Biomet 3i's BellaTek Zirconia Dental Abutment fractures were received.
March 19, 2014Medical DevicesFDA
Biomet 3i, LLC recalls Contra-Angle Torque Driver Kit For Certain and External Connection Product Usage: Molded plastic tray used in holdin
Hazard: During recent revised sterilization validation testing, the included surgical trays did not meet the Sterility Assurance Level required.
March 19, 2014Medical DevicesFDA
Biomet 3i, LLC recalls Contra-Angle Torque Driver Kit For Certain Internal Connection Product Usage: Molded plastic tray used in holding va
Hazard: During recent revised sterilization validation testing, the included surgical trays did not meet the Sterility Assurance Level required.
March 19, 2014Medical DevicesFDA
Biomet 3i, LLC recalls Contra-Angle Torque Driver Kit Product Usage: Molded plastic tray used in holding various dental instruments for aut
Hazard: During recent revised sterilization validation testing, the included surgical trays did not meet the Sterility Assurance Level required.