Biomet 3i Recalls
222 recalls on record · June 27, 2012 to October 14, 2020 · Medical Devices
Recalls by year
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Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
March 19, 2014Medical DevicesFDA
Biomet 3i, LLC recalls Tapered Navigator Certain Surgical Kit Product Usage: Molded plastic tray used in holding various dental instruments
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 Navigator Surgical Kit Product Usage: Molded plastic tray used in holding various dental instruments for autoclave p
Hazard: During recent revised sterilization validation testing, the included surgical trays did not meet the Sterility Assurance Level required.
September 25, 2013Medical DevicesFDA
Biomet 3i, LLC recalls Osseotite Parallel Walled Certain 4mm(D)X 15mm (L) Dental Implant Product Usage: Surgical placement in the upper or
Hazard: One of the dental implants do not have the internal hex feature. One of the dental implants do not have the internal thread feature.
September 25, 2013Medical DevicesFDA
Biomet 3i, LLC recalls Osseotite 2 Certain Prevail 5mm(D)X 4.1mm (P) X X 11.5mm (L) Dental Implant Product Usage: Surgical placement in the
Hazard: One of the dental implants do not have the internal hex feature. One of the dental implants do not have the internal thread feature.
August 21, 2013Medical DevicesFDA
Biomet 3i, LLC recalls Biomet 3i Dental Implant, Non-Platform Switched Parallel Walled Implant 5mm (D) x 13mm (L)
Hazard: A small number of outer implant boxes may be mislabeled. The inner tray, containing the implant, is label correctly. This condition, if present and not recognized could potentially result in the dental implant not being able to be placed into the osteotomy or seated to the desired depth if placement is attempted.
August 21, 2013Medical DevicesFDA
Biomet 3i, LLC recalls Biomet 3i Dental Implant, Parallel Walled 6mm (D) x 10mm (L)
Hazard: A small number of outer implant boxes may be mislabeled. The inner tray, containing the implant, is label correctly. This condition, if present and not recognized could potentially result in the dental implant not being able to be placed into the osteotomy or seated to the desired depth if placement is attempted.
November 28, 2012Medical DevicesFDA
Biomet 3i, LLC recalls Product is Full OSSEOTITE Parallel Walled Certain Implant, Model Number IFOA411. The product is sterile. Product pro
Hazard: Biomet 3i recalled Full OSSEOTITE 2 Tapered Certain Implant and Full OSSEOTITE Parallel Walled Certain Implant due to a manufacturing condition where the depth of the implant's internal hex is too shallow. This condition may prevent the driver or abutment from fully engaging in the implant.
November 28, 2012Medical DevicesFDA
Biomet 3i, LLC recalls Product is Full OSSEOTITE 2 Tapered Certain Implant, Model Number XIFNT413, and size 4 x 13 mm. The product is sterile.
Hazard: Biomet 3i recalled Full OSSEOTITE 2 Tapered Certain Implant and Full OSSEOTITE Parallel Walled Certain Implant due to a manufacturing condition where the depth of the implant's internal hex is too shallow. This condition may prevent the driver or abutment from fully engaging in the implant.
October 31, 2012Medical DevicesFDA
Biomet 3i, LLC recalls Osseotite Tapered Certain Implant 5 X 10mm Model INT510 Biomet 3i Dental Implants are intended for surgical placement
Hazard: Biomet 3i recalled their Osseotite Tapered Certain Implant, Model # INT510 due to a small percentage of the devices are missing the internal threading.
September 5, 2012Medical DevicesFDA
Biomet 3i, LLC recalls Low Profile Abutment, Non-Hexed Castable Cylinder Model LPCCC1. Product is labeled in part: "***REF LPCCC1***Low profi
Hazard: Biomet 3i conducted a recall on the device Low Profile Abutment, Non-Hexed Castable Cylinder due to some packages labeled LPCCC1, Hexed Castable Cylinder possibly containing LPCCC2, Non-Hexed Castable Cylinders.
August 15, 2012Medical DevicesFDA
Biomet 3i, LLC recalls ***REF IFNT611***Full OSSEOTITE Tapered Certain Implant 6 x 11.5mm***Sterile by radiation***Rx Only***BIOMET 3i Dental I
Hazard: Biomet 3i is recalling their product Full Osseotite Tapered Certain Implant IFNT611. The depth of the implant's internal hex is too shallow. The condition, if present, may prevent the driver; cover screw or abutment from fully engaging the implant.
June 27, 2012Medical DevicesFDA
Biomet 3i, LLC recalls Implant, Dental, Endosseous, Acid Etched, ICE, Osseotite, Internal Connection. . Product is labeled in part: "***C
Hazard: On November 3, 2011 Biomet 3i, Palm Beach Gardens, FL initiated a recall of their Osseotite Certain Implant, Model # IOSM313, Lot #2010111529. Dental implant lot may not have an internal thread.