PlainRecalls

Biomet 3i, LLC

139 recalls on record · Latest: Oct 14, 2020

FDA Devices Moderate Aug 24, 2016

Healing Abutment Dental implants

FDA Devices Moderate Aug 24, 2016

Locator Replacement Housing Kit Dental implants

FDA Devices Moderate Aug 24, 2016

Certain Gingihue Post 5mm(D) x 5mm(P) x 2mm(H) Item: IWPP552G Dental implants

FDA Devices Moderate Aug 24, 2016

Implant Cover Screw Dental implants

FDA Devices Moderate Aug 24, 2016

IOL Abutment and Screw Dental implants

FDA Devices Moderate Aug 24, 2016

Drill Stop Dental implants

FDA Devices Moderate Aug 24, 2016

Certain EP Healing Abutment 5mm(D) x 5.6mm(P) x 4mm(H) Item: IWTH54 Dental implants

FDA Devices Moderate Aug 24, 2016

Provide Impression Coping Dental implants

FDA Devices Moderate Aug 24, 2016

O-Ring Abutment 4.1mm(D) x 6mm(H) Item: OSO60 Dental implants

FDA Devices Moderate Aug 24, 2016

Standard Abutment Pick -Up Coping Dental implants

FDA Devices Moderate Aug 24, 2016

Implant EP Twist Lock TM Coping Dental implants

FDA Devices Moderate Aug 24, 2016

Certain Pick-Up Coping 4.1mm(D) x 5mm(P) Item: IIIC12 Dental implants

FDA Devices Moderate Aug 24, 2016

Certain Temporary Hexed Cylinder Dental implants

FDA Devices Moderate Aug 24, 2016

Conical EP Pick-Up Coping (Hexed) Dental implants

FDA Devices Moderate Aug 24, 2016

Conical 17 degree Angled Abutment Dental implants

FDA Devices Moderate Aug 24, 2016

Prep-Tite Post Dental implants

FDA Devices Moderate Aug 24, 2016

Titanium Hexed Uniscrew Dental implants

FDA Devices Moderate Aug 24, 2016

Certain Flat Implant Cover Screw Dental implants

FDA Devices Moderate Aug 24, 2016

Certain Titanium Large Hexed Screw Dental implants

FDA Devices Moderate Aug 24, 2016

EP Healing Abutment Dental implants

FDA Devices Moderate Jan 13, 2016

BIOMET 3i, PROVIDE IMPRESSION COPING KITS, Catalog # PRK484, PRK485, PRK654, and PRK655 BIOMET 3i Restorative Products are intended for use as an…

FDA Devices Moderate Jan 13, 2016

BIOMET 3i, PROVIDE PROTECTION CAP, Catalog # PPC484, PPC485, PPC654, and PPC655 BIOMET 3i Restorative Products are intended for use as an accessor…

FDA Devices Moderate Jan 6, 2016

Radiographic Transparency for Certain and External Connection Tapered Implants. Images that assist with measurements for dental implants.

FDA Devices Moderate Apr 22, 2015

OSSEOTITE Tapered Certain Implant Rx Only; 3.25 x 18.5 - 15.0 mm. Dental Implants.

FDA Devices Moderate Apr 22, 2015

OSSEOTITE Certain 2 Implant Rx only; 3.25 x 8.5 - 18 mm. Dental Implants.

FDA Devices Moderate Sep 17, 2014

BIOMET 3i Certain Bellatek Encode Healing Abutment Biomet 3i Healing abutments are temporary abutments indicated for use in maintaining the soft …

FDA Devices Moderate Apr 23, 2014

BIOMET 3i Endosseous Dental Implant.

FDA Devices Low Mar 26, 2014

ENDOBON XENOGRAFT GRANULES 0.5 ML (Bovine bone substitute) Endobon is a bone substitute of bovine origin formed from ceramised bone for implantati…

FDA Devices Moderate Mar 26, 2014

Dental Abutment labeled in part: "4555 Riverside Drive Palm Beach Gardens, FL 33410 USA 1-800-342-5454***EDAZ , EDAZx and ILDExxx***BellaTek Zirconi…

FDA Devices Moderate Mar 19, 2014

Tapered Navigator Certain Surgical Kit Product Usage: Molded plastic tray used in holding various dental instruments for autoclave processing.

FDA Devices Moderate Mar 19, 2014

Navigator Surgical Kit Product Usage: Molded plastic tray used in holding various dental instruments for autoclave processing.

FDA Devices Moderate Sep 25, 2013

Osseotite 2 Certain Prevail 5mm(D)X 4.1mm (P) X X 11.5mm (L) Dental Implant Product Usage: Surgical placement in the upper or lower jaw to provid…

FDA Devices Moderate Aug 21, 2013

Biomet 3i Dental Implant, Non-Platform Switched Parallel Walled Implant 5mm (D) x 13mm (L)

FDA Devices Moderate Aug 21, 2013

Biomet 3i Dental Implant, Parallel Walled 6mm (D) x 10mm (L)

FDA Devices Moderate Nov 28, 2012

Product is Full OSSEOTITE Parallel Walled Certain Implant, Model Number IFOA411. The product is sterile. Product provides a means for prosthetic …

FDA Devices Moderate Oct 31, 2012

Osseotite Tapered Certain Implant 5 X 10mm Model INT510 Biomet 3i Dental Implants are intended for surgical placement in the upper or lower jaw to…

FDA Devices Moderate Sep 5, 2012

Low Profile Abutment, Non-Hexed Castable Cylinder Model LPCCC1. Product is labeled in part: "***REF LPCCC1***Low profile Abutment Hexed Castable Cy…

FDA Devices Moderate Aug 15, 2012

***REF IFNT611***Full OSSEOTITE Tapered Certain Implant 6 x 11.5mm***Sterile by radiation***Rx Only***BIOMET 3i Dental Iberica S.L. WTC Almeda Park, …

FDA Devices Moderate Jun 27, 2012

Implant, Dental, Endosseous, Acid Etched, ICE, Osseotite, Internal Connection. . Product is labeled in part: "***Certain 3.25, 13***REF IOSM313…