471 results
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47ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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OSSEOTITE
FDA Adverse Event
Injury
·BIOMET 3I, LLC·Product code DZE·August 9, 2023
IMPLANT, ENDOSSEOUS, ROOT-FORM
FDA Adverse Event
Malfunction
·BIOMET 3I, LLC·Product code DZE·August 12, 2023
ENCODE
FDA Adverse Event
Injury
·BIOMET 3I, LLC·Product code NHA·August 9, 2023
DENTAL IMPLANT
FDA Adverse Event
Injury
·BIOMET 3I, LLC.·Product code DZE·June 5, 2024
PANA SPLAY PLUS
FDA Adverse Event
Malfunction
·BIOMET 3I LLC·Product code EFB·June 20, 2024
DENTAL IMPLANT
FDA Adverse Event
Malfunction
·BIOMET 3I, LLC·Product code NDP·May 30, 2023
DENTAL IMPLANT
FDA Adverse Event
Malfunction
·BIOMET 3I, LLC·Product code NDP·May 30, 2023
DENTAL IMPLANT
FDA Adverse Event
Malfunction
·BIOMET 3I, LLC·Product code NDP·May 30, 2023
DENTAL IMPLANT
FDA Adverse Event
Injury
·BIOMET 3I, LLC·Product code DZE·April 10, 2025
3i Custom # 5753, OSCM2913, 2.9MMX 3.4MM X 13MM, OSSEOTITE CUSTOM, MICROMINI IMPLANT, LOT # 470258, Sterile. Implant Innovations, Inc. 4555 Riverside Drive, Palm Beach Gardens, FL 33410. Custom temporary cover screws are for use in maintaining the soft tissue during the healing process of a dental restoration.
FDA Recall
Terminated
·Biomet 3i, LLC·Product code NDA·December 11, 2006
ABUTMENT, IMPLANT DENTAL ENDOSSEOUS
FDA Adverse Event
Injury
·ZIMVIE / BIOMET 3I, LLC·Product code NHA·July 24, 2024
DENTAL ABUTMENT
FDA Adverse Event
Injury
·ZIMVIE/BIOMET 3I, LLC·Product code NHA·August 1, 2024
Certain Low-Profile, Angled Abutment, Model Number ILPAC3217. Product is labeled in part: "***Biomet 3i***4555 Riverside Drive , Palm Beach Gardens, FL 33410 USA***REF ILPAC3217***LOT 2011091179***Certain Low Profile 17 Abutment***3.4mm(D) X 2mm(H)***Abutment:; Pillar; Abutment; Abutment; Pilastro; Pillar***CE dose***Use by 2016-09***Sterile using Radiation***RX Only***Do not reuse***Consult accompanying documents***Do not re-sterilize***Do not use if package is damaged***ILPAC3217***2011091179***"P-LBLNY3P***Rev. D***". Intended to provide a means to attach crown restorations or implant frameworks to implants.
FDA Recall
Terminated
·Biomet 3i, LLC·Product code NHA·January 10, 2012
"***BIOMET 3i***4555 Riverside Drive Palm Beach Gardens FL 33410 USA***REF AC4425***Conical 25 ANGLED ABUTMENT***4.1mm(D) X 4mm(H)***Abutment; Pilier: Abutment; Abutment; Pilastro; Pilar***RX Only***Sterile***BIOMET 3i Dental Iberica S.L. WTC Almeda Park. Ed. 1. Planta 1'***". Attach an implant to an implant restoration.
FDA Recall
Terminated
·Biomet 3i, LLC·Product code NHA·September 28, 2011
"***BIOMET 3i***4555 Riverside Drive Palm Beach Gardens FL 33410 USA***REF SWCA62***Conical Abutment Gold Standard ZR***6mm(D) X 2mm(H)***Abutment; Pilier: Abutment; Abutment; Pilastro; Pilar***RX Only***Sterile***BIOMET 3i Dental Iberica S.L. WTC Almeda Park. Ed. 1. Planta 1'***". Attach an implant to an implant restoration.
FDA Recall
Terminated
·Biomet 3i, LLC·Product code NHA·September 28, 2011
***REF INT411***OSSEOTITE Tapered Certain Implant 4 x 11.5mm***Sterile Using Radiation***Rx Only***BIOMET 3i Dental lberica S.L.WTC Almeda Park, Ed, 1 Planta 1 Pl. de la Pau s/n08940 Cornella de Llobregat (Barcelona) Spain***Phone +34 934-705-500; Fax +34 933-717-849. Biomet 3i Dental Implants are intended for surgical placement in the upper or lower jaw to provide a means for prosthetic attachment in single tooth restorations and in partially or fully edentulous spans with multiple single teeth utilizing delayed or immediate loading or with a terminal or intermediary abutment for fixed or removable bridgework and to retain over dentures.
FDA Recall
Terminated
·Biomet 3i, LLC·Product code O-FY·March 10, 2011
LARGE HEX SCREWDRIVER
FDA Adverse Event
Malfunction
·ZIMMER INC. (BIOMET 3I, LLC )·Product code HXX·April 24, 2018
Contra-Angle Torque Driver Kit For Certain and External Connection Product Usage: Molded plastic tray used in holding various dental instruments for autoclave processing.
FDA Recall
Terminated
·Biomet 3i, LLC·Product code LRO·July 22, 2013
BIOMET 3i Certain Bellatek Encode Healing Abutment Biomet 3i Healing abutments are temporary abutments indicated for use in maintaining the soft tissue opening throughout the healing process prior to dental restoration.
FDA Recall
Terminated
·Biomet 3i, LLC·Product code NHA·June 25, 2014
"***REF IWTH56***Certain EP HEALING ABUTMENT 5mm(D) X 5mm(P) X 6mm(H).*** Healing abutment*** STERILE.***Rx Only.*** Made in USA*** Implant Innovations, Inc. Global Headquarters 4555 Riverside Drive, Palm Beach Gardens, FL 33410 USA Tel: (800) 342-5454 www.3i.online.com. Outside US 561-776-6700***Implant Innovations Siberica S.L., WTC Almeda Park, Ed. 1 Planta 1a Pl. De la Pau s/n 08940-Cornella de Llobregat (Barcelona) Spain. Phone: +34 934 705500. Fax +34 933 717 849. Lot Number: 602691.***" Biomet 3i healing abutments are temporary healing abutments for use in maintaining the soft tissue opening throughout the healing process of dental restoration.
FDA Recall
Terminated
·Biomet 3i, LLC·Product code NSQ·February 23, 2010