PlainRecalls

Nobel Biocare Usa Llc

42 recalls on record · Latest: Mar 2, 2022

Nobel Biocare Usa Llc Recall Insight

Nobel Biocare Usa Llc appears on 42 federal recall records indexed by PlainRecalls, out of 83,949 total recalls tracked across the FDA, CPSC, NHTSA, and USDA FSIS. That represents approximately 0.050% of the federal archive — a data point that is only interpretable alongside production volume, product mix, and decades of operation, because a high recall count alone does not establish fault. Large, diversified firms that sell tens of millions of units across many categories will mechanically accumulate more recall records than small manufacturers, even when their defect rates per unit shipped are comparable or lower. The most recent action on this firm is dated Mar 2, 2022, which is the anchor point for assessing whether enforcement is currently active or historical.

On this page of 42 entries, severity tagging shows 0 critical, 42 moderate, and 0 lower-severity recalls. Affected-unit counts are disclosed on 41 of 42 entries — unit-count disclosure is more common on CPSC and NHTSA actions and less common on FDA drug/device recalls, where lot numbers and distribution scope substitute for absolute totals. The records on this page span 1 distinct product categories, with issuing agencies dominated by FDA Devices (42). The date window on this page runs from Nov 20, 2013 to Mar 2, 2022.

Manufacturer-level browsing is useful when monitoring a single firm for patterns — whether recalls cluster around one product family (suggesting a specific design or supplier issue) or scatter across the firm's entire catalog (which can indicate systemic quality-control problems or deliberate regulator attention). Clicking into each recall reveals the specific hazard, remedy, and distribution scope that together determine whether a consumer is actually at risk. For decisions that depend on being current — deciding whether a product in your home is safe, whether to return a gift, or whether to accept a replacement — always verify the recall number on the issuing agency's site, because federal agencies amend, terminate, and re-scope recalls over time and only the agency's live record reflects the current legal status. This page aggregates what agencies have published publicly and is intended for consumer awareness and research.

FDA Devices Moderate Mar 2, 2022

NobelReplace Conical Connection RP 4.3x11.5 mm REF 36707 STERILE R

FDA Devices Moderate Jun 10, 2020

NobelActive Internal NP 3.5x15mm Endosseus dental implant, REF: 34128, Rx Only, Sterile R, CE, UDI: (01)07332747010619

FDA Devices Moderate May 13, 2020

Esthetic Abutment CC RP 1.5 mm pre-manufactured prosthetic components directly connected to the endosseous implant, catalog no. 36669 - Product Usage…

FDA Devices Moderate May 13, 2020

Temporary Abutment Engaging CC RP pre-manufactured prosthetic components directly connected to the endosseous implant, catalog no. 36664 - - Product …

FDA Devices Moderate May 13, 2020

NobelParallel Conical Connection NP, 3.75x10mm (Endosseous Dental Implant); REF 37965; UDI (01)07332747091441(10)12129104(17)240203 - Product Usage:…

FDA Devices Moderate May 13, 2020

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 scre…

FDA Devices Moderate May 13, 2020

Temporary Snap Abutment Engaging CC RP 1.5 mm; Pre-manufactured prosthetic components directly connected to the endosseous implant; catalog no. 38761…

FDA Devices Moderate Feb 26, 2020

Guided Start Drills/Counterbore NobRpl NP - Product Usage: The Guided Drills (Twist (Step) Drills, Guided Tapered Drills) are used for preparing oste…

FDA Devices Moderate Feb 26, 2020

Drill Tapered NP 3.5x11.5 mm Single-Pat - Product Usage: The Guided Drills (Twist (Step) Drills, Guided Tapered Drills) are used for preparing osteot…

FDA Devices Moderate Feb 26, 2020

Drill Tapered RP 4.3x11.5 mm Single-Pat - Product Usage: The Guided Drills (Twist (Step) Drills, Guided Tapered Drills) are used for preparing osteot…

FDA Devices Moderate Feb 26, 2020

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 …

FDA Devices Moderate Feb 26, 2020

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 imp…

FDA Devices Moderate Feb 26, 2020

Screw Tap Tapered WP Single-Pat - Product Usage: The Guided Drills (Twist (Step) Drills, Guided Tapered Drills) are used for preparing osteotomies fo…

FDA Devices Moderate Feb 26, 2020

Abutment Screw Retrieval Instrument 3.0/NP - Product Usage: The instruments for abutment screw retrieval can be used if an abutment screw is broken a…

FDA Devices Moderate Feb 26, 2020

Abutment Screw Retrieval Kit - Product Usage: The kit itself does not have a specific intended Use, but included devices have specific intended use a…

FDA Devices Moderate Feb 26, 2020

Drill Tapered NP 3.5x10 mm Single-Pat - Product Usage: The Guided Drills (Twist (Step) Drills, Guided Tapered Drills) are used for preparing osteotom…

FDA Devices Moderate Feb 26, 2020

Dense Bone Drill 6.0 6x16 mm Single-Pat- Product Usage: The Guided Drills (Twist (Step) Drills, Guided Tapered Drills) are used for preparing osteoto…

FDA Devices Moderate Feb 26, 2020

Drill Tapered NP 3.5x8 mm Single-Pat - Product Usage: The Guided Drills (Twist (Step) Drills, Guided Tapered Drills) are used for preparing osteotomi…

FDA Devices Moderate Feb 26, 2020

Implant Retrieval Instrument Hex & Tri-Chi NP/RP 31mm - Product Usage: They can be used to remove implants, if the implant connection has been damage…

FDA Devices Moderate Feb 26, 2020

Drill Tapered WP 5x11.5 mm Single-Pat - Product Usage: Drills are intended to be used in the upper and lower jaw bone to prepare osteotomy prior to i…

FDA Devices Moderate Aug 1, 2018

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 u…

FDA Devices Moderate Aug 17, 2016

Instructions for Use (IFU) and Manual NobPrl CC Guided Surgery Kit Instructions for Use (IFU): "NobelGuide for NobelParallel Conical Connection", …

FDA Devices Moderate Jul 27, 2016

Replace Select Tapered TiU NP 3.5x11.5mm, Article No. 36105 Replace Select Tapered implants are root-form endosseous implants intended to be surgica…

FDA Devices Moderate Jul 22, 2015

Abutment Retrieval Instrument Zirconia CC RP/WP, Article No. 37882 and Abutment Retrieval Kit, Article No. 37508 (Article No. 37882 was assembled in …

FDA Devices Moderate Apr 22, 2015

NobelReplace CC PMC RP 5.0x13mm, Article No. 37298.

FDA Devices Moderate Apr 22, 2015

Replace Select Tapered TiU RP 4.3x11.5mm, Article No. 36107.

FDA Devices Moderate Apr 22, 2015

NobelReplace CC NP 3.5x10mm, Article No. 36700.

FDA Devices Moderate Apr 22, 2015

NobelReplace CC PMC NP 3.5x13mm, Article No. 37288.

FDA Devices Moderate Apr 22, 2015

NOBELREPLACE Tapered Groovy RP 4.3x10mm, Article No. 32216. Nobel Biocare's Dental Implants are root-form endosseous implants intended to be surgica…

FDA Devices Moderate Apr 22, 2015

NobelReplace CC PMC RP 4.3x8mm, Article No. 37290.

FDA Devices Moderate Apr 22, 2015

NobelReplace CC RP 4.3x8mm, Article No. 36704.

FDA Devices Moderate Apr 22, 2015

NobelReplace CC NP 3.5x13mm, Article No. 36702.

FDA Devices Moderate Apr 22, 2015

NobelReplace CC NP 3.5x11.5mm, Article No. 36701.

FDA Devices Moderate Apr 22, 2015

Replace Select Tapered TiU NP 3.5x11.5mm, Article No. 36105. Nobel Biocare's Dental Implants are root-form endosseous implants intended to be surgic…

FDA Devices Moderate Apr 22, 2015

NobelReplace CC PMC RP 5.0x10mm, Article No. 37296.

FDA Devices Moderate Apr 22, 2015

NobelReplace CC RP 4.3x10mm, Article No. 36705.

FDA Devices Moderate Apr 22, 2015

NOBELREPLACE Tapered Groovy 6.0 6x8mm, Article No. 32223. Nobel Biocare's Dental Implants are root-form endosseous implants intended to be surgicall…

FDA Devices Moderate Apr 22, 2015

NobelReplace CC RP 5.0x10mm, Article No. 36711.

FDA Devices Moderate Apr 22, 2015

NobelReplace CC RP 4.3x11.5mm, Article No. 36707.

FDA Devices Moderate Apr 22, 2015

Replace Select Tapered TiU NP 3.5x13mm, Article No. 29402. Nobel Biocare's Dental Implants are root-form endosseous implants intended to be surgical…

FDA Devices Moderate Apr 22, 2015

NobelReplace CC PMC NP 3.5x11.5mm, Article No. 37287.

FDA Devices Moderate Nov 20, 2013

Osseocare Pro Console & Set Osseocare Pro, Model 1600870-001, 1700470-001, and 1700471-001. Device Name: Osseocare Pro console & Set Osseocare Pro…

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Data Sources

  • Source: FDA + CPSC + NHTSA + USDA FSIS — federal recall filings naming this firm. Verify with FDA, CPSC, NHTSA, or USDA FSIS directly.
  • Source: PlainRecalls Manufacturer Index — firm-level aggregation across all four federal recall feeds