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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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22
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 2, 2022Medical DevicesFDA
Nobel Biocare Usa Llc recalls NobelReplace Conical Connection RP 4.3x11.5 mm REF 36707 STERILE R
Hazard: Due to 16 complaints related to drivers not engaging in implants. According to the firm's investigations, the incorrect offset gauge was potentially used during production of the implants. As a result, this could potentially lead to aborted or a delay in surgical procedure.
June 10, 2020Medical DevicesFDA
Nobel Biocare Usa Llc recalls Healing Abutment Conical Connection RP 0 3.6 x 5mm, REF: 36644, UDI: 07332747034462 - Product Usage: Dental implant abut
Hazard: Packaged dental implant healing abutments were found to contain the wrong size device.
June 10, 2020Medical DevicesFDA
Nobel Biocare Usa Llc recalls NobelActive Internal NP 3.5x15mm Endosseus dental implant, REF: 34128, Rx Only, Sterile R, CE, UDI: (01)07332747010619
Hazard: The top label for dental implant may incorrectly indicate the implant length. Specifically, the label may contain 11.5mm for the length, which is shorter than the actual length of the implant (15mm). An incorrect sized implant may cause patient discomfort, permanent nerve damage and may require an additional surgery.
May 13, 2020Medical DevicesFDA
Nobel Biocare Usa Llc recalls Temporary Snap Abutment Engaging CC RP 1.5 mm; Pre-manufactured prosthetic components directly connected to the endosseo
Hazard: Packages of abutments may contain an incorrect screw. While the screw will tighten, it cannot be guaranteed that the screw will not loosen. In case the screw loosens the abutment should be retightened with the correct screw.
May 13, 2020Medical DevicesFDA
Nobel Biocare Usa Llc recalls Universal Base CC RP 1.5 mm; The Universal Base Abutment in combination with Nobel Biocare end osseous implants are indi
Hazard: Packages of abutments (universal base) may contain an incorrect screw. While the screw will tighten, it cannot be guaranteed that the screw will not loosen. In case the screw loosens the abutment should be retightened with the correct screw.
May 13, 2020Medical DevicesFDA
Nobel Biocare Usa Llc recalls Snappy Abutment 5.5 CC RP 3 mm; pre-manufactured prosthetic components directly connected to the endosseous implant, cat
Hazard: Packages of abutments may contain an incorrect screw. While the screw will tighten, it cannot be guaranteed that the screw will not loosen. In case the screw loosens the abutment should be retightened with the correct screw.
May 13, 2020Medical DevicesFDA
Nobel Biocare Usa Llc recalls Esthetic Abutment CC RP 1.5 mm pre-manufactured prosthetic components directly connected to the endosseous implant, cata
Hazard: Packages of abutments may contain an incorrect screw. While the screw will tighten, it cannot be guaranteed that the screw will not loosen. In case the screw loosens the abutment should be retightened with the correct screw.
May 13, 2020Medical DevicesFDA
Nobel Biocare Usa Llc recalls Temporary Abutment Engaging CC RP pre-manufactured prosthetic components directly connected to the endosseous implant, c
Hazard: Packages of abutments may contain an incorrect screw. While the screw will tighten, it cannot be guaranteed that the screw will not loosen. In case the screw loosens the abutment should be retightened with the correct screw.
May 13, 2020Medical DevicesFDA
Nobel Biocare Usa Llc recalls Temporary Abutment Non-Engaging CC RP pre-manufactured prosthetic components directly connected to the endosseous implan
Hazard: Packages of abutments may contain an incorrect screw. While the screw will tighten, it cannot be guaranteed that the screw will not loosen. In case the screw loosens the abutment should be retightened with the correct screw.
May 13, 2020Medical DevicesFDA
Nobel Biocare Usa Llc recalls NobelParallel Conical Connection NP, 3.75x10mm (Endosseous Dental Implant); REF 37965; UDI (01)07332747091441(10)121291
Hazard: The top label of article no. 37965, lot 12129104 (immediate packaging of endosseous dental implants ) may incorrectly indicate an implant length of 7mm, which is shorter than the actual length of the implant (10mm).
February 26, 2020Medical DevicesFDA
Nobel Biocare Usa Llc recalls Abutment Screw Retrieval Instrument RP/WP/6.0 - Product Usage: The instruments for abutment screw retrieval can be 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 Abutment Screw Retrieval Kit - Product Usage: The kit itself does not have a specific intended Use, but included devices
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 Implant Retrieval Kit - Product Usage: The kit itself does not have a specific intended Use, but included devices have s
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 Abutment Screw Retrieval Instrument 3.0/NP - Product Usage: The instruments for abutment screw retrieval can be used if
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 Implant Retrieval Instrument Tri Channel 6.0 22 mm - Product Usage: They can be used to remove implants, if the implant
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 Implant Retrieval Instrument CC RP & Tri Ch Hex WP 22 mm - Product Usage: They can be used to remove implants, if the i
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 Implant Retrieval Instrument CC NP & Ext Hex WP 22 mm - Product Usage: They can be used to remove implants, if the impla
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 Implant Retrieval Instrument CC 3.0 31 mm- Product Usage: They can be used to remove implants, if the implant connection
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 Implant Retrieval Instrument Hex & Tri-Chi NP/RP 31mm - Product Usage: They can be used to remove implants, if the impla
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 Implant Retrieval Instrument Hex & Tri-Ch NP/RP 22mm - Product Usage: They can be used to remove implants, if the implan
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 WP 5x13 mm Single-Pat - Product Usage: Drills are intended to be used in the upper and lower jaw bone t
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 NP 3.5x16 mm Single-Pat - Product Usage: Drills are intended to be used in the upper and lower jaw bone
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 6.0 6x8 mm Single-Pat - Product Usage: Drills are intended to be used in the upper and lower jaw bone to p
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 WP 5x11.5 mm Single-Pat - Product Usage: Drills are intended to be used in the upper and lower jaw bone to
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 WP 5x10 mm Single-Pat - Product Usage: Drills are intended to be used in the upper and lower jaw bone to p
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 RP 4.3x13 mm Single-Pat - Product Usage: The Guided Drills (Twist (Step) Drills, Guided Tapered Drills) ar
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 RP 4.3x11.5 mm Single-Pat - 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.
February 26, 2020Medical DevicesFDA
Nobel Biocare Usa Llc recalls Drill Tapered RP 4.3x10 mm Single-Pat - Product Usage: The Guided Drills (Twist (Step) Drills, Guided Tapered Drills) ar
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 3.5x11.5 mm Single-Pat - 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.
February 26, 2020Medical DevicesFDA
Nobel Biocare Usa Llc recalls Drill Tapered NP 3.5x10 mm Single-Pat - Product Usage: The Guided Drills (Twist (Step) Drills, Guided Tapered Drills) ar
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.