The Recall Desk

Manufacturer

Nobel Biocare Usa Llc

66 recalls in our database name Nobel Biocare Usa Llc as the manufacturing or recalling firm.

What the numbers show

Total
66
Critical
0
Severe
1
Most recent
2022-03-02

Of the 66 recalls from Nobel Biocare Usa Llc we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 1 (2%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

26–50 of 66

  • ModerateFDA (Devices)·Z-1324-2020·2020-02-26

    Nobel Biocare Recalls Abutment Screw Retrieval Kits Due to Sterility Concerns

    Nobel Biocare is recalling 7 units of Abutment Screw Retrieval Kits because a packaging sealing issue may compromise the sterility of the included medical devices.

    Product
    Abutment Screw Retrieval Kit - Product Usage: The kit itself does not have a specific intended Use, but included devices have specific intended use as shown above.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1302-2020·2020-02-26

    Nobel Biocare Recalls Guided Start Drills Due to Sterility Concerns

    Nobel Biocare is recalling Guided Start Drills because a packaging sealing issue may compromise the sterility of the devices during their shelf life.

    Product
    Guided Start Drills/Counterbore NobRpl NP - Product Usage: The Guided Drills (Twist (Step) Drills, Guided Tapered Drills) are used for preparing osteotomies for the specific related implants
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1313-2020·2020-02-26

    Nobel Biocare Dental Drills Recalled Due to Sterility Concerns

    Nobel Biocare is recalling specific dental drills because a packaging defect may compromise their sterility during shelf life.

    Product
    Drill Tapered 6.0 6x8 mm Single-Pat - Product Usage: Drills are intended to be used in the upper and lower jaw bone to prepare osteotomy prior to implant placement.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1306-2020·2020-02-26

    Nobel Biocare Tapered Drills Recalled Due to Sterility Concerns

    Nobel Biocare is recalling specific tapered dental drills because a packaging defect may compromise their sterility during shelf life.

    Product
    Drill Tapered NP 3.5x10 mm Single-Pat - Product Usage: The Guided Drills (Twist (Step) Drills, Guided Tapered Drills) are used for preparing osteotomies for the specific related implants.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1309-2020·2020-02-26

    Nobel Biocare Recalls Tapered Dental Drills Due to Sterility Concerns

    Nobel Biocare is recalling 260 units of tapered dental drills because a packaging sealing issue may compromise sterility during shelf life.

    Product
    Drill Tapered RP 4.3x11.5 mm Single-Pat - Product Usage: The Guided Drills (Twist (Step) Drills, Guided Tapered Drills) are used for preparing osteotomies for the specific related implants.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1321-2020·2020-02-26

    Nobel Biocare Implant Retrieval Instruments Recalled for Sterility Concerns

    Nobel Biocare is recalling 11 units of Implant Retrieval Instrument Tri Channel 6.0 22 mm because a packaging sealing issue may compromise sterility.

    Product
    Implant Retrieval Instrument Tri Channel 6.0 22 mm - Product Usage: They can be used to remove implants, if the implant connection has been damaged. It can be used to remove implants with internal conical connection, internal tri-channel connection or external hex connection.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1325-2020·2020-02-26

    Nobel Biocare Abutment Screw Retrieval Instruments Recalled for Sterility Concerns

    Nobel Biocare is recalling 132 units of Abutment Screw Retrieval Instrument RP/WP/6.0 because a packaging sealing issue may compromise sterility during shelf life.

    Product
    Abutment Screw Retrieval Instrument RP/WP/6.0 - Product Usage: The instruments for abutment screw retrieval can be used if an abutment screw is broken and a part of the screw is left inside the implant screw channel. If the implant thread needs to be cleaned before placing a new
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1323-2020·2020-02-26

    Nobel Biocare Recalls Implant Retrieval Kits Due to Sterility Concerns

    Nobel Biocare is recalling 87 units of Implant Retrieval Kits because a packaging sealing issue may compromise the sterility of the devices during their shelf-life.

    Product
    Implant Retrieval Kit - Product Usage: The kit itself does not have a specific intended Use, but included devices have specific intended use as shown above.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1316-2020·2020-02-26

    Nobel Biocare Implant Retrieval Instruments Recalled for Sterility Concerns

    Nobel Biocare is recalling 2,470 implant retrieval instruments because a packaging defect may compromise sterility. The devices are distributed worldwide.

    Product
    Implant Retrieval Instrument Hex & Tri-Ch NP/RP 22mm - Product Usage: They can be used to remove implants, if the implant connection has been damaged. It can be used to remove implants with internal conical connection, internal tri-channel connection or external hex connection.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2529-2018·2018-08-01

    Nobel Biocare Multi-Unit Abutment Recalled for Missing Label Information

    Nobel Biocare is recalling 74 units of Multi-Unit Abutments because the product labels are missing the lot number, expiration date, and other required information.

    Product
    Nobel Biocare 17¿ Multi-Unit Abutment, Conical Connection NP, 2.5mm, REF 36614. Product Usage: Intended to be used in the upper and lower jaw and used for supporting tooth replacements to restore chewing function. The Multi-Unit Abutments, in combination with endosseous implant
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2375-2016·2016-08-17

    Nobel Biocare Recalls Guided Surgery Kit Instructions for Incorrect Drill Protocol

    Nobel Biocare is recalling 231 Guided Surgery Kits because the Instructions for Use contain an incorrect drill protocol. The kits are used for NobelParallel CC Implants.

    Product
    Instructions for Use (IFU) and Manual NobPrl CC Guided Surgery Kit Instructions for Use (IFU): "NobelGuide for NobelParallel Conical Connection", id # 2002 and Manual: Guided Surgery with NobelParallel Conical Connection", id # 79423. Article # 38072, Nobel Parallel CC Guided
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2237-2016·2016-07-27

    Nobel Biocare Dental Implants Recalled for Incorrect Top Label

    Nobel Biocare is recalling 53 Replace Select Tapered dental implants due to incorrect top labels on the packaging. The recall covers units distributed in the US and internationally.

    Product
    Replace Select Tapered TiU NP 3.5x11.5mm, Article No. 36105 Replace Select Tapered implants are root-form endosseous implants intended to be surgically placed in the bone of the upper and lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in or
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-2074-2015·2015-07-22

    Nobel Biocare Recalls Zirconia Abutment Retrieval Instruments Due to Dimensional Error

    Nobel Biocare is recalling 149 units of Zirconia Abutment Retrieval Instruments and Kits because a dimensional error prevents the instruments from removing metal adapters as intended.

    Product
    Abutment Retrieval Instrument Zirconia CC RP/WP, Article No. 37882 and Abutment Retrieval Kit, Article No. 37508 (Article No. 37882 was assembled in this kit). Used to remove a zirconia abutment if the abutment is stuck in the implant connection due to a tight seat. Endosseous
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1431-2015·2015-04-22

    Nobel Biocare Recalls Dental Implants Due to Packaging Material Issue

    Nobel Biocare is recalling specific NobelReplace dental implants because packaging material may leave a sticky substance on the implant surfaces.

    Product
    NobelReplace CC RP 4.3x13mm, Article No. 36708.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1436-2015·2015-04-22

    NobelReplace Dental Implants Recalled for Packaging Material Contamination

    Nobel Biocare is recalling 23 units of NobelReplace CC PMC NP dental implants because packaging material may leave a sticky substance on the implant surfaces.

    Product
    NobelReplace CC PMC NP 3.5x13mm, Article No. 37288.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1419-2015·2015-04-22

    Nobel Biocare Recalls Dental Implants Due to Packaging Material Defect

    Nobel Biocare is recalling 138 dental implant units because packaging material may leave a sticky substance on the implant surfaces.

    Product
    NOBELREPLACE Tapered Groovy RP 4.3x8mm, Article No. 32215. Nobel Biocare's Dental Implants are root-form endosseous implants intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as an artificial tooth, in o
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1414-2015·2015-04-22

    Nobel Biocare Recalls Dental Implants Due to Packaging Material Contamination

    Nobel Biocare is recalling 131 units of Replace Select Tapered TiU NP dental implants because packaging material may leave a sticky substance on the implant surfaces.

    Product
    Replace Select Tapered TiU NP 3.5x10mm, Article No. 29401. Nobel Biocare's Dental Implants are root-form endosseous implants intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as an artificial tooth, in o
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1420-2015·2015-04-22

    Nobel Biocare Recalls Dental Implants Due to Packaging Contamination

    Nobel Biocare is recalling 74 dental implants because packaging material may leave a sticky substance on the implant surfaces.

    Product
    NOBELREPLACE Tapered Groovy RP 4.3x10mm, Article No. 32216. Nobel Biocare's Dental Implants are root-form endosseous implants intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as an artificial tooth, in
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1438-2015·2015-04-22

    NobelReplace Dental Implants Recalled Due to Packaging Material Contamination

    Nobel Biocare is recalling 5 units of NobelReplace dental implants because packaging material may leave a sticky substance on the implant surfaces.

    Product
    NobelReplace CC PMC RP 4.3x10mm, Article No. 37291.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1428-2015·2015-04-22

    Nobel Biocare Recalls Dental Implants Due to Packaging Material Contamination

    Nobel Biocare is recalling 102 units of NobelReplace CC RP dental implants because packaging material may leave a sticky substance on the implant surfaces.

    Product
    NobelReplace CC RP 4.3x8mm, Article No. 36704.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1427-2015·2015-04-22

    Nobel Biocare Recalls Dental Implants Due to Packaging Material Contamination

    Nobel Biocare is recalling 594 units of NobelReplace CC NP dental implants because packaging material may leave a sticky substance on the implant surfaces.

    Product
    NobelReplace CC NP 3.5x13mm, Article No. 36702.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1423-2015·2015-04-22

    Nobel Biocare Recalls Dental Implants Due to Packaging Material Issue

    Nobel Biocare is recalling 23 dental implants because packaging material may leave a sticky substance on the implant surfaces.

    Product
    Replace Select Tapered TiU NP 3.5x11.5mm, Article No. 36105. Nobel Biocare's Dental Implants are root-form endosseous implants intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as an artificial tooth, in
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1439-2015·2015-04-22

    Nobel Biocare Recalls Dental Implants Due to Packaging Material Contamination

    Nobel Biocare is recalling 53 units of NobelReplace CC PMC RP 5.0x10mm dental implants because packaging material may leave a sticky substance on the implant surfaces.

    Product
    NobelReplace CC PMC RP 5.0x10mm, Article No. 37296.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1421-2015·2015-04-22

    Nobel Biocare Recalls Dental Implants Due to Packaging Material Contamination

    Nobel Biocare is recalling 7 dental implants because packaging material may leave a sticky substance on the implant surfaces.

    Product
    NOBELREPLACE Tapered Groovy 6.0 6x8mm, Article No. 32223. Nobel Biocare's Dental Implants are root-form endosseous implants intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as an artificial tooth, in or
    Category
    Medical Device
    Distribution
    Distributed nationwide

About this company

Community-sourced company facts from Wikidata, not from any recall agency. This is background on the corporate entity — it says nothing about the recall(s) listed on this page, which come from the agency source notice above.

Nobel Biocare

company

Founded
1981
Parent company
Danaher Corporation

Official website

Source: Wikidata (Q672725), licensed CC0. Wikidata is community-edited and may not reflect the current corporate structure.