Recall archive
10 recalls · page 1 of 1
Reported Mar 2, 2022
NobelReplace Conical Connection RP 4.3x11.5 mm REF 36707 STERILE R
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Nobel Biocare USA LLC
Matched: Brand · Product · Product details — Due to 16 complaints related to drivers not engaging in implants. According to the firm's investigations, the incorrect offset gauge was potentially…
FDA (openFDA device enforcement)
Reported Jun 10, 2020
NobelActive Internal NP 3.5x15mm Endosseus dental implant, REF: 34128, Rx Only, Sterile R, CE, UDI: (01)07332747010619
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Nobel Biocare USA LLC
Matched: Brand · Product · Product details — The top label for dental implant may incorrectly indicate the implant length. Specifically, the label may contain 11.5mm for the length, which is…
1 more product in this recall
FDA (openFDA device enforcement)
Reported May 13, 2020
NobelParallel Conical Connection NP, 3.75x10mm (Endosseous Dental Implant); REF 37965; UDI…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Nobel Biocare USA LLC
Matched: Brand · Product · Product details — The top label of article no. 37965, lot 12129104 (immediate packaging of endosseous dental implants ) may incorrectly indicate an implant length of…
6 more products in this recall
FDA (openFDA device enforcement)
Reported Feb 26, 2020
Guided Start Drills/Counterbore NobRpl NP - Product Usage: The Guided Drills (Twist (Step) Drills, Guided Tapered…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Nobel Biocare USA LLC
Matched: Brand · Product · Product details — Due to a problem in the packaging sealing process at the supplier of the affected devices, it cannot be guaranteed that the sterilized medical…
23 more products in this recall
FDA (openFDA device enforcement)
Reported Aug 1, 2018
Nobel Biocare 17¿ Multi-Unit Abutment, Conical Connection NP, 2.5mm, REF 36614. Product Usage: Intended to be used in…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Nobel Biocare USA LLC
Matched: Brand · Product · Product details — The product label has missing information, such as the lot number and expiration date, as well as other information.
FDA (openFDA device enforcement)
Reported Aug 17, 2016
Instructions for Use (IFU) and Manual NobPrl CC Guided Surgery Kit Instructions for Use (IFU): "NobelGuide for…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Nobel Biocare USA LLC
Matched: Brand · Product · Product details — Incorrect drill protocol in the Instructions for Use (IFU)
FDA (openFDA device enforcement)
Reported Jul 27, 2016
Replace Select Tapered TiU NP 3.5x11.5mm, Article No. 36105 Replace Select Tapered implants are root-form endosseous…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Nobel Biocare USA LLC
Matched: Brand — Incorrect top label on an implant package.
FDA (openFDA device enforcement)
Reported Jul 22, 2015
Abutment Retrieval Instrument Zirconia CC RP/WP, Article No. 37882 and Abutment Retrieval Kit, Article No. 37508…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Nobel Biocare USA LLC
Matched: Brand — One dimension of the affected instrument is incorrect. Therefore this instrument cannot be used to remove the metal adapter as intended.
FDA (openFDA device enforcement)
Reported Apr 22, 2015
Replace Select Tapered TiU NP 3.5x10mm, Article No. 29401. Nobel Biocare's Dental Implants are root-form endosseous…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Nobel Biocare USA LLC
Matched: Brand · Product · Product details — A material used in the packaging of the dental implants may impart a sticky substance on the top surfaces of the implants and in some cases on the…
26 more products in this recall
FDA (openFDA device enforcement)
Reported Nov 20, 2013
Osseocare Pro Console & Set Osseocare Pro, Model 1600870-001, 1700470-001, and 1700471-001. Device Name: Osseocare Pro…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Nobel Biocare USA LLC
Matched: Brand — The recall was initiated because there is a potential for malfunction of the OsseoCare Pro when used with the OseeoCare Pro iPad application software…
FDA (openFDA device enforcement)
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