Nobel Biocare Usa Llc
Complete recall history across all FDA and CPSC categories — 66 total recalls
Nobel Biocare Usa Llc appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.
Device Recalls (66)
FDA medical device enforcement actions by Nobel Biocare Usa Llc. Showing most recent 50.
| Date | Product | Reason | Class |
|---|---|---|---|
| Dec 17, 2021 | NobelReplace Conical Connection RP 4.3x11.5 mm REF 36707 STERILE R | Due to 16 complaints related to drivers not engaging in implants. According ... | Class II |
| Aug 28, 2019 | NobelParallel Conical Connection NP, 3.75x10mm (Endosseous Dental Implant); R... | The top label of article no. 37965, lot 12129104 (immediate packaging of endo... | Class II |
| Aug 9, 2019 | Snappy Abutment 5.5 CC RP 3 mm; pre-manufactured prosthetic components direct... | Packages of abutments may contain an incorrect screw. While the screw will ti... | Class II |
| Aug 9, 2019 | Temporary Abutment Non-Engaging CC RP pre-manufactured prosthetic components ... | Packages of abutments may contain an incorrect screw. While the screw will ti... | Class II |
| Aug 9, 2019 | Temporary Snap Abutment Engaging CC RP 1.5 mm; Pre-manufactured prosthetic co... | Packages of abutments may contain an incorrect screw. While the screw will ti... | Class II |
| Aug 9, 2019 | Universal Base CC RP 1.5 mm; The Universal Base Abutment in combination with ... | Packages of abutments (universal base) may contain an incorrect screw. While ... | Class II |
| Aug 9, 2019 | Temporary Abutment Engaging CC RP pre-manufactured prosthetic components dire... | Packages of abutments may contain an incorrect screw. While the screw will ti... | Class II |
| Aug 9, 2019 | Esthetic Abutment CC RP 1.5 mm pre-manufactured prosthetic components directl... | Packages of abutments may contain an incorrect screw. While the screw will ti... | Class II |
| Jul 19, 2019 | NobelActive Internal NP 3.5x15mm Endosseus dental implant, REF: 34128, Rx Onl... | The top label for dental implant may incorrectly indicate the implant length.... | Class II |
| May 28, 2019 | Healing Abutment Conical Connection RP 0 3.6 x 5mm, REF: 36644, UDI: 07332747... | Packaged dental implant healing abutments were found to contain the wrong siz... | Class II |
| Mar 14, 2019 | Drill Tapered RP 4.3x13 mm Single-Pat - Product Usage: The Guided Drills (Twi... | Due to a problem in the packaging sealing process at the supplier of the affe... | Class II |
| Mar 14, 2019 | Implant Retrieval Instrument Tri Channel 6.0 22 mm - Product Usage: They can ... | Due to a problem in the packaging sealing process at the supplier of the affe... | Class II |
| Mar 14, 2019 | Abutment Screw Retrieval Instrument RP/WP/6.0 - Product Usage: The instrument... | Due to a problem in the packaging sealing process at the supplier of the affe... | Class II |
| Mar 14, 2019 | Implant Retrieval Kit - Product Usage: The kit itself does not have a specifi... | Due to a problem in the packaging sealing process at the supplier of the affe... | Class II |
| Mar 14, 2019 | Implant Retrieval Instrument Hex & Tri-Ch NP/RP 22mm - Product Usage: They ca... | Due to a problem in the packaging sealing process at the supplier of the affe... | Class II |
| Mar 14, 2019 | Drill Tapered RP 4.3x10 mm Single-Pat - Product Usage: The Guided Drills (Twi... | Due to a problem in the packaging sealing process at the supplier of the affe... | Class II |
| Mar 14, 2019 | Implant Retrieval Instrument CC RP & Tri Ch Hex WP 22 mm - Product Usage: Th... | Due to a problem in the packaging sealing process at the supplier of the affe... | Class II |
| Mar 14, 2019 | Implant Retrieval Instrument CC 3.0 31 mm- Product Usage: They can be used to... | Due to a problem in the packaging sealing process at the supplier of the affe... | Class II |
| Mar 14, 2019 | Implant Retrieval Instrument CC NP & Ext Hex WP 22 mm - Product Usage: They c... | Due to a problem in the packaging sealing process at the supplier of the affe... | Class II |
| Mar 14, 2019 | Dense Bone Drill NP 3.5x16 mm Single-Pat - Product Usage: Drills are intended... | Due to a problem in the packaging sealing process at the supplier of the affe... | Class II |
| Mar 14, 2019 | Drill Tapered 6.0 6x8 mm Single-Pat - Product Usage: Drills are intended to b... | Due to a problem in the packaging sealing process at the supplier of the affe... | Class II |
| Mar 14, 2019 | Drill Tapered WP 5x11.5 mm Single-Pat - Product Usage: Drills are intended to... | Due to a problem in the packaging sealing process at the supplier of the affe... | Class II |
| Mar 14, 2019 | Implant Retrieval Instrument Hex & Tri-Chi NP/RP 31mm - Product Usage: They c... | Due to a problem in the packaging sealing process at the supplier of the affe... | Class II |
| Mar 14, 2019 | Drill Tapered NP 3.5x8 mm Single-Pat - Product Usage: The Guided Drills (Twis... | Due to a problem in the packaging sealing process at the supplier of the affe... | Class II |
| Mar 14, 2019 | Dense Bone Drill 6.0 6x16 mm Single-Pat- Product Usage: The Guided Drills (Tw... | Due to a problem in the packaging sealing process at the supplier of the affe... | Class II |
| Mar 14, 2019 | Drill Tapered NP 3.5x10 mm Single-Pat - Product Usage: The Guided Drills (Twi... | Due to a problem in the packaging sealing process at the supplier of the affe... | Class II |
| Mar 14, 2019 | Abutment Screw Retrieval Kit - Product Usage: The kit itself does not have a ... | Due to a problem in the packaging sealing process at the supplier of the affe... | Class II |
| Mar 14, 2019 | Abutment Screw Retrieval Instrument 3.0/NP - Product Usage: The instruments f... | Due to a problem in the packaging sealing process at the supplier of the affe... | Class II |
| Mar 14, 2019 | Screw Tap Tapered WP Single-Pat - Product Usage: The Guided Drills (Twist (St... | Due to a problem in the packaging sealing process at the supplier of the affe... | Class II |
| Mar 14, 2019 | Drill Tapered WP 5x10 mm Single-Pat - Product Usage: Drills are intended to b... | Due to a problem in the packaging sealing process at the supplier of the affe... | Class II |
| Mar 14, 2019 | Dense Bone Drill WP 5x13 mm Single-Pat - Product Usage: Drills are intended t... | Due to a problem in the packaging sealing process at the supplier of the affe... | Class II |
| Mar 14, 2019 | Drill Tapered RP 4.3x11.5 mm Single-Pat - Product Usage: The Guided Drills (T... | Due to a problem in the packaging sealing process at the supplier of the affe... | Class II |
| Mar 14, 2019 | Drill Tapered NP 3.5x11.5 mm Single-Pat - Product Usage: The Guided Drills (T... | Due to a problem in the packaging sealing process at the supplier of the affe... | Class II |
| Mar 14, 2019 | Guided Start Drills/Counterbore NobRpl NP - Product Usage: The Guided Drills ... | Due to a problem in the packaging sealing process at the supplier of the affe... | Class II |
| Mar 16, 2018 | Nobel Biocare 17¿ Multi-Unit Abutment, Conical Connection NP, 2.5mm, REF 3661... | The product label has missing information, such as the lot number and expirat... | Class II |
| Jul 20, 2016 | Instructions for Use (IFU) and Manual NobPrl CC Guided Surgery Kit Instruc... | Incorrect drill protocol in the Instructions for Use (IFU) | Class II |
| Jun 22, 2016 | Replace Select Tapered TiU NP 3.5x11.5mm, Article No. 36105 Replace Select T... | Incorrect top label on an implant package. | Class II |
| Jun 22, 2015 | Abutment Retrieval Instrument Zirconia CC RP/WP, Article No. 37882 and Abutme... | One dimension of the affected instrument is incorrect. Therefore this instrum... | Class II |
| Mar 9, 2015 | NOBELREPLACE Tapered Groovy RP 4.3x8mm, Article No. 32215. Nobel Biocare's D... | A material used in the packaging of the dental implants may impart a sticky s... | Class II |
| Mar 9, 2015 | NobelReplace CC PMC RP 4.3x10mm, Article No. 37291. | A material used in the packaging of the dental implants may impart a sticky s... | Class II |
| Mar 9, 2015 | NobelReplace CC RP 5.0x8mm, Article No. 36710. | A material used in the packaging of the dental implants may impart a sticky s... | Class II |
| Mar 9, 2015 | Replace Select Tapered TiU NP 3.5x10mm, Article No. 29401. Nobel Biocare's D... | A material used in the packaging of the dental implants may impart a sticky s... | Class II |
| Mar 9, 2015 | NobelReplace CC RP 4.3x13mm, Article No. 36708. | A material used in the packaging of the dental implants may impart a sticky s... | Class II |
| Mar 9, 2015 | NobelReplace CC RP 5.0x13mm, Article No. 36713. | A material used in the packaging of the dental implants may impart a sticky s... | Class II |
| Mar 9, 2015 | Replace Select Tapered TiU WP 5.0x13mm, Article No. 29424. Nobel Biocare's D... | A material used in the packaging of the dental implants may impart a sticky s... | Class II |
| Mar 9, 2015 | Replace Select Tapered TiU NP 3.5x16mm, Article No. 29403. Nobel Biocare's D... | A material used in the packaging of the dental implants may impart a sticky s... | Class II |
| Mar 9, 2015 | NobRpl Tapered Groovy 6.0mm 6x11.5mm, Article No. 36103. Nobel Biocare's Den... | A material used in the packaging of the dental implants may impart a sticky s... | Class II |
| Mar 9, 2015 | Replace Select Tapered TiU WP 5.0x10mm, Article No. 29423. Nobel Biocare's D... | A material used in the packaging of the dental implants may impart a sticky s... | Class II |
| Mar 9, 2015 | NobelReplace CC PMC NP 3.5x11.5mm, Article No. 37287. | A material used in the packaging of the dental implants may impart a sticky s... | Class II |
| Mar 9, 2015 | Replace Select Tapered TiU NP 3.5x13mm, Article No. 29402. Nobel Biocare's D... | A material used in the packaging of the dental implants may impart a sticky s... | Class II |
Frequently Asked Questions
A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.
Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.
The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.
Yes. You can search for any company using the firm/manufacturer pages for each category: Food Firms, Drug Firms, Device Firms, or Product Manufacturers. You can also use the search functionality on any browse page to find recalls by company name.
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