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.

1–25 of 66

  • HighFDA (Devices)·Z-0658-2022·2022-03-02

    NobelReplace dental implant components recalled for driver engagement defect

    Nobel Biocare is recalling 702 NobelReplace dental implant components due to a manufacturing defect that prevents proper driver engagement. The defect could result in aborted or delayed surgical procedures.

    Product
    NobelReplace Conical Connection RP 4.3x11.5 mm REF 36707 STERILE R
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2207-2020·2020-06-10

    Nobel Biocare Recalls Dental Implants Due to Incorrect Length Labeling

    Nobel Biocare is recalling 221 dental implants because the label may incorrectly state the length as 11.5mm instead of the actual 15mm, posing a risk of nerve damage.

    Product
    NobelActive Internal NP 3.5x15mm Endosseus dental implant, REF: 34128, Rx Only, Sterile R, CE, UDI: (01)07332747010619
    Category
    Medical Device
    Distribution
    28 states
  • ModerateFDA (Devices)·Z-2250-2020·2020-06-10

    Nobel Biocare Recalls Dental Implant Healing Abutments Due to Sizing Error

    Nobel Biocare is recalling specific dental implant healing abutments because they were packaged with the wrong size device.

    Product
    Healing Abutment Conical Connection RP 0 3.6 x 5mm, REF: 36644, UDI: 07332747034462 - Product Usage: Dental implant abutments are intended to be used in the upper or lower jaw and used for supporting tooth replacements to restore chewing function. The Healing Abutment is intended
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1855-2020·2020-05-13

    Nobel Biocare Recalls Dental Implant Abutments Due to Incorrect Screws

    Nobel Biocare is recalling 215 Snappy Abutment 5.5 CC RP 3 mm units because they may contain incorrect screws that could loosen.

    Product
    Snappy Abutment 5.5 CC RP 3 mm; pre-manufactured prosthetic components directly connected to the endosseous implant, catalog no. 36683 - - Product Usage: Dental implant abutments are intended to be used in the upper or lower jaw and used for supporting tooth replacements to resto
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1851-2020·2020-05-13

    Nobel Biocare Dental Implant Recall Due to Incorrect Length Labeling

    Nobel Biocare is recalling 228 dental implants because the packaging label incorrectly lists the length as 7mm instead of the actual 10mm.

    Product
    NobelParallel Conical Connection NP, 3.75x10mm (Endosseous Dental Implant); REF 37965; UDI (01)07332747091441(10)12129104(17)240203 - Product Usage: are intended to be used in the upper or lower jaw bone (osseointegration) and used for anchoring or supporting tooth replacements
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1853-2020·2020-05-13

    Nobel Biocare Recalls Dental Implant Abutments Due to Incorrect Screw Risk

    Nobel Biocare is recalling 239 units of Temporary Abutment Engaging CC RP components because packages may contain incorrect screws that could loosen.

    Product
    Temporary Abutment Engaging CC RP pre-manufactured prosthetic components directly connected to the endosseous implant, catalog no. 36664 - - Product Usage: Dental implant abutments are intended to be used in the upper or lower jaw and used for supporting tooth replacements to res
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1856-2020·2020-05-13

    Nobel Biocare Universal Base Abutments Recalled for Incorrect Screws

    Nobel Biocare is recalling 238 Universal Base CC RP 1.5 mm abutments because they may contain incorrect screws that could loosen.

    Product
    Universal Base CC RP 1.5 mm; The Universal Base Abutment in combination with Nobel Biocare end osseous implants are indicated for single-unit if screw retained and for multiple-unit if cement retained crowns are used; catalog no. 38214 - Product Usage: Dental implant abutments ar
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1852-2020·2020-05-13

    Nobel Biocare Recalls Dental Implant Abutments Due to Incorrect Screw Risk

    Nobel Biocare is recalling 236 units of temporary dental implant abutments because packages may contain an incorrect screw that could loosen.

    Product
    Temporary Abutment Non-Engaging CC RP pre-manufactured prosthetic components directly connected to the endosseous implant, catalog no. 36662 - Product Usage: Dental implant abutments are intended to be used in the upper or lower jaw and used for supporting tooth replacements to r
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1854-2020·2020-05-13

    Nobel Biocare Recalls Dental Abutments Due to Incorrect Screw Risk

    Nobel Biocare is recalling 227 Esthetic Abutment CC RP 1.5 mm units because they may contain incorrect screws that could loosen.

    Product
    Esthetic Abutment CC RP 1.5 mm pre-manufactured prosthetic components directly connected to the endosseous implant, catalog no. 36669 - Product Usage: Dental implant abutments are intended to be used in the upper or lower jaw and used for supporting tooth replacements to restore
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1857-2020·2020-05-13

    Nobel Biocare Recalls Dental Implant Abutments Due to Incorrect Screws

    Nobel Biocare is recalling 478 Temporary Snap Abutments because packages may contain incorrect screws that could loosen, requiring retightening.

    Product
    Temporary Snap Abutment Engaging CC RP 1.5 mm; Pre-manufactured prosthetic components directly connected to the endosseous implant; catalog no. 38761 - Product Usage: Dental implant abutments are intended to be used in the upper or lower jaw and used for supporting tooth replacem
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1303-2020·2020-02-26

    Nobel Biocare Recalls Tapered Dental Drills Due to Sterility Concerns

    Nobel Biocare is recalling 8 units of tapered dental drills because a packaging sealing issue may compromise sterility during shelf life.

    Product
    Drill Tapered NP 3.5x8 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
  • HighFDA (Devices)·Z-1319-2020·2020-02-26

    Nobel Biocare Recalls Implant Retrieval Instruments Due to Sterility Concerns

    Nobel Biocare is recalling 423 implant retrieval instruments because a packaging defect may compromise sterility during shelf life.

    Product
    Implant Retrieval Instrument CC NP & Ext Hex WP 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
  • HighFDA (Devices)·Z-1308-2020·2020-02-26

    Nobel Biocare Guided Tapered Drills Recalled for Sterility Concerns

    Nobel Biocare is recalling 346 Guided Tapered Drills because a packaging sealing issue may compromise sterility during shelf life.

    Product
    Drill Tapered RP 4.3x10 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
  • HighFDA (Devices)·Z-1314-2020·2020-02-26

    Nobel Biocare Dense Bone Drill Recall Due to Sterility Concerns

    Nobel Biocare is recalling Dense Bone Drills because a packaging sealing issue may compromise sterility during shelf life.

    Product
    Dense Bone Drill NP 3.5x16 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
  • HighFDA (Devices)·Z-1317-2020·2020-02-26

    Nobel Biocare Implant Retrieval Instruments Recalled for Sterility Concerns

    Nobel Biocare is recalling 197 implant retrieval instruments because a packaging defect may compromise sterility during shelf life.

    Product
    Implant Retrieval Instrument Hex & Tri-Chi NP/RP 31mm - 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
  • HighFDA (Devices)·Z-1307-2020·2020-02-26

    Nobel Biocare Recalls Tapered Drills Due to Sterility Concerns

    Nobel Biocare is recalling 473 tapered dental drills because a packaging defect may compromise sterility during shelf life.

    Product
    Drill Tapered NP 3.5x11.5 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
  • HighFDA (Devices)·Z-1322-2020·2020-02-26

    Nobel Biocare Abutment Screw Retrieval Instruments Recalled for Sterility Concerns

    Nobel Biocare is recalling 233 units of Abutment Screw Retrieval Instruments because a packaging defect may compromise sterility during shelf life.

    Product
    Abutment Screw Retrieval Instrument 3.0/NP - 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 scr
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1311-2020·2020-02-26

    Nobel Biocare Dental Drills Recalled Due to Packaging Seal Defects

    Nobel Biocare is recalling 264 tapered dental drills because a packaging sealing defect may compromise sterility during shelf life.

    Product
    Drill Tapered WP 5x10 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
  • HighFDA (Devices)·Z-1315-2020·2020-02-26

    Nobel Biocare Dense Bone Drills Recalled for Sterility Concerns

    Nobel Biocare is recalling Dense Bone Drills because a packaging defect may compromise sterility during shelf life.

    Product
    Dense Bone Drill WP 5x13 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
  • HighFDA (Devices)·Z-1318-2020·2020-02-26

    Nobel Biocare Implant Retrieval Instrument Recall Due to Sterility Concerns

    Nobel Biocare is recalling 31 units of Implant Retrieval Instrument CC 3.0 31 mm because a packaging sealing defect may compromise sterility.

    Product
    Implant Retrieval Instrument CC 3.0 31 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
  • HighFDA (Devices)·Z-1310-2020·2020-02-26

    Nobel Biocare Tapered Drills Recalled Due to Sterility Concerns

    Nobel Biocare is recalling 154 units of Tapered RP 4.3x13 mm drills because a packaging defect may compromise sterility.

    Product
    Drill Tapered RP 4.3x13 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
  • HighFDA (Devices)·Z-1305-2020·2020-02-26

    Nobel Biocare Recalls Screw Taps Due to Packaging Seal Defects

    Nobel Biocare is recalling Screw Tap Tapered WP Single-Pat devices because a packaging sealing defect may compromise sterility during shelf life.

    Product
    Screw Tap Tapered WP 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-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-1304-2020·2020-02-26

    Nobel Biocare Dense Bone Drills Recalled for Sterility Concerns

    Nobel Biocare is recalling 8 Dense Bone Drills because a packaging defect may compromise sterility during shelf life.

    Product
    Dense Bone Drill 6.0 6x16 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

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.