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Nobel Biocare Usa Recalls
66 recalls on record · November 20, 2013 to March 2, 2022 · 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.
February 26, 2020Medical DevicesFDA
Nobel Biocare Usa Llc recalls Screw Tap Tapered WP Single-Pat - Product Usage: The Guided Drills (Twist (Step) Drills, Guided Tapered Drills) are used
Hazard: Due to a problem in the packaging sealing process at the supplier of the affected devices, it cannot be guaranteed that the sterilized medical devices in the scope of this recall remain sterile during their shelf-life.
February 26, 2020Medical DevicesFDA
Nobel Biocare Usa Llc recalls Dense Bone Drill 6.0 6x16 mm Single-Pat- Product Usage: The Guided Drills (Twist (Step) Drills, Guided Tapered Drills) a
Hazard: Due to a problem in the packaging sealing process at the supplier of the affected devices, it cannot be guaranteed that the sterilized medical devices in the scope of this recall remain sterile during their shelf-life.
February 26, 2020Medical DevicesFDA
Nobel Biocare Usa Llc recalls Drill Tapered NP 3.5x8 mm Single-Pat - Product Usage: The Guided Drills (Twist (Step) Drills, Guided Tapered Drills) are
Hazard: Due to a problem in the packaging sealing process at the supplier of the affected devices, it cannot be guaranteed that the sterilized medical devices in the scope of this recall remain sterile during their shelf-life.
February 26, 2020Medical DevicesFDA
Nobel Biocare Usa Llc recalls Guided Start Drills/Counterbore NobRpl NP - Product Usage: The Guided Drills (Twist (Step) Drills, Guided Tapered Drills
Hazard: Due to a problem in the packaging sealing process at the supplier of the affected devices, it cannot be guaranteed that the sterilized medical devices in the scope of this recall remain sterile during their shelf-life.
August 1, 2018Medical DevicesFDA
Nobel Biocare Usa Llc recalls Nobel Biocare 17¿ Multi-Unit Abutment, Conical Connection NP, 2.5mm, REF 36614. Product Usage: Intended to be used in
Hazard: The product label has missing information, such as the lot number and expiration date, as well as other information.
August 17, 2016Medical DevicesFDA
Nobel Biocare Usa Llc recalls Instructions for Use (IFU) and Manual NobPrl CC Guided Surgery Kit Instructions for Use (IFU): "NobelGuide for NobelP
Hazard: Incorrect drill protocol in the Instructions for Use (IFU)
July 27, 2016Medical DevicesFDA
Nobel Biocare Usa Llc recalls Replace Select Tapered TiU NP 3.5x11.5mm, Article No. 36105 Replace Select Tapered implants are root-form endosseous im
Hazard: Incorrect top label on an implant package.
July 22, 2015Medical DevicesFDA
Nobel Biocare Usa Llc recalls Abutment Retrieval Instrument Zirconia CC RP/WP, Article No. 37882 and Abutment Retrieval Kit, Article No. 37508 (Articl
Hazard: One dimension of the affected instrument is incorrect. Therefore this instrument cannot be used to remove the metal adapter as intended.
April 22, 2015Medical DevicesFDA
Nobel Biocare Usa Llc recalls NobelReplace CC PMC RP 5.0x13mm, Article No. 37298.
Hazard: A material used in the packaging of the dental implants may impart a sticky substance on the top surfaces of the implants and in some cases on the first threads.
April 22, 2015Medical DevicesFDA
Nobel Biocare Usa Llc recalls NobelReplace CC PMC RP 5.0x10mm, Article No. 37296.
Hazard: A material used in the packaging of the dental implants may impart a sticky substance on the top surfaces of the implants and in some cases on the first threads.
April 22, 2015Medical DevicesFDA
Nobel Biocare Usa Llc recalls NobelReplace CC PMC RP 4.3x10mm, Article No. 37291.
Hazard: A material used in the packaging of the dental implants may impart a sticky substance on the top surfaces of the implants and in some cases on the first threads.
April 22, 2015Medical DevicesFDA
Nobel Biocare Usa Llc recalls NobelReplace CC PMC RP 4.3x8mm, Article No. 37290.
Hazard: A material used in the packaging of the dental implants may impart a sticky substance on the top surfaces of the implants and in some cases on the first threads.
April 22, 2015Medical DevicesFDA
Nobel Biocare Usa Llc recalls NobelReplace CC PMC NP 3.5x13mm, Article No. 37288.
Hazard: A material used in the packaging of the dental implants may impart a sticky substance on the top surfaces of the implants and in some cases on the first threads.
April 22, 2015Medical DevicesFDA
Nobel Biocare Usa Llc recalls NobelReplace CC PMC NP 3.5x11.5mm, Article No. 37287.
Hazard: A material used in the packaging of the dental implants may impart a sticky substance on the top surfaces of the implants and in some cases on the first threads.
April 22, 2015Medical DevicesFDA
Nobel Biocare Usa Llc recalls NobelReplace CC RP 5.0x13mm, Article No. 36713.
Hazard: A material used in the packaging of the dental implants may impart a sticky substance on the top surfaces of the implants and in some cases on the first threads.
April 22, 2015Medical DevicesFDA
Nobel Biocare Usa Llc recalls NobelReplace CC RP 5.0x10mm, Article No. 36711.
Hazard: A material used in the packaging of the dental implants may impart a sticky substance on the top surfaces of the implants and in some cases on the first threads.
April 22, 2015Medical DevicesFDA
Nobel Biocare Usa Llc recalls NobelReplace CC RP 5.0x8mm, Article No. 36710.
Hazard: A material used in the packaging of the dental implants may impart a sticky substance on the top surfaces of the implants and in some cases on the first threads.
April 22, 2015Medical DevicesFDA
Nobel Biocare Usa Llc recalls NobelReplace CC RP 4.3x13mm, Article No. 36708.
Hazard: A material used in the packaging of the dental implants may impart a sticky substance on the top surfaces of the implants and in some cases on the first threads..
April 22, 2015Medical DevicesFDA
Nobel Biocare Usa Llc recalls NobelReplace CC RP 4.3x11.5mm, Article No. 36707.
Hazard: A material used in the packaging of the dental implants may impart a sticky substance on the top surfaces of the implants and in some cases on the first threads.
April 22, 2015Medical DevicesFDA
Nobel Biocare Usa Llc recalls NobelReplace CC RP 4.3x10mm, Article No. 36705.
Hazard: A material used in the packaging of the dental implants may impart a sticky substance on the top surfaces of the implants and in some cases on the first threads.
April 22, 2015Medical DevicesFDA
Nobel Biocare Usa Llc recalls NobelReplace CC RP 4.3x8mm, Article No. 36704.
Hazard: A material used in the packaging of the dental implants may impart a sticky substance on the top surfaces of the implants and in some cases on the first threads.
April 22, 2015Medical DevicesFDA
Nobel Biocare Usa Llc recalls NobelReplace CC NP 3.5x13mm, Article No. 36702.
Hazard: A material used in the packaging of the dental implants may impart a sticky substance on the top surfaces of the implants and in some cases on the first threads.
April 22, 2015Medical DevicesFDA
Nobel Biocare Usa Llc recalls NobelReplace CC NP 3.5x11.5mm, Article No. 36701.
Hazard: A material used in the packaging of the dental implants may impart a sticky substance on the top surfaces of the implants and in some cases on the first threads.
April 22, 2015Medical DevicesFDA
Nobel Biocare Usa Llc recalls NobelReplace CC NP 3.5x10mm, Article No. 36700.
Hazard: A material used in the packaging of the dental implants may impart a sticky substance on the top surfaces of the implants and in some cases on the first threads.
April 22, 2015Medical DevicesFDA
Nobel Biocare Usa Llc recalls Replace Select Tapered TiU RP 4.3x11.5mm, Article No. 36107.
Hazard: A material used in the packaging of the dental implants may impart a sticky substance on the top surfaces of the implants and in some cases on the first threads.
April 22, 2015Medical DevicesFDA
Nobel Biocare Usa Llc recalls Replace Select Tapered TiU NP 3.5x11.5mm, Article No. 36105. Nobel Biocare's Dental Implants are root-form endosseous i
Hazard: A material used in the packaging of the dental implants may impart a sticky substance on the top surfaces of the implants and in some cases on the first threads.
April 22, 2015Medical DevicesFDA
Nobel Biocare Usa Llc recalls NobRpl Tapered Groovy 6.0mm 6x11.5mm, Article No. 36103. Nobel Biocare's Dental Implants are root-form endosseous impla
Hazard: A material used in the packaging of the dental implants may impart a sticky substance on the top surfaces of the implants and in some cases on the first threads.
April 22, 2015Medical DevicesFDA
Nobel Biocare Usa Llc recalls NOBELREPLACE Tapered Groovy 6.0 6x8mm, Article No. 32223. Nobel Biocare's Dental Implants are root-form endosseous impl
Hazard: A material used in the packaging of the dental implants may impart a sticky substance on the top surfaces of the implants and in some cases on the first threads.
April 22, 2015Medical DevicesFDA
Nobel Biocare Usa Llc recalls NOBELREPLACE Tapered Groovy RP 4.3x10mm, Article No. 32216. Nobel Biocare's Dental Implants are root-form endosseous im
Hazard: A material used in the packaging of the dental implants may impart a sticky substance on the top surfaces of the implants and in some cases on the first threads.
April 22, 2015Medical DevicesFDA
Nobel Biocare Usa Llc recalls NOBELREPLACE Tapered Groovy RP 4.3x8mm, Article No. 32215. Nobel Biocare's Dental Implants are root-form endosseous imp
Hazard: A material used in the packaging of the dental implants may impart a sticky substance on the top surfaces of the implants and in some cases on the first threads.