PlainRecalls
FDA Devices Moderate Class II Terminated

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 order to restore patient esthetics and chewing function. Nobel Biocare's Dental Implants are indicated for single or multiple unit restorations in splinted or non-splinted applications. Dental Implants may be placed imme

Reported: April 22, 2015 Initiated: March 9, 2015 #Z-1420-2015

Product Description

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 order to restore patient esthetics and chewing function. Nobel Biocare's Dental Implants are indicated for single or multiple unit restorations in splinted or non-splinted applications. Dental Implants may be placed immediately and put into immediate function providing that the initial stability requirements detailed in the surgical manuals are satisfied.

Reason for Recall

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 first threads.

Details

Recalling Firm
Nobel Biocare Usa Llc
Units Affected
74 units
Distribution
Worldwide Distribution - US (nationwide) and Internationally to Austria, Australia, Belgium, Bulgaria, Canada, Switzerland, Czech Republic, Germany, Denmark, Estonia, Spain, Finland, France, United Kingdom, Greece, Croatia, Hungary, Ireland, Italy, Lithuania, Luxembourg, Mexico, Netherlands, Norway, Poland, Portugal, Romania, Russian Fed., Saudi Arabia, Sweden, Turkey, and United Arab Emirates.
Location
Yorba Linda, CA

Frequently Asked Questions

What product was recalled? ▼
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 order to restore patient esthetics and chewing function. Nobel Biocare's Dental Implants are indicated for single or multiple unit restorations in splinted or non-splinted applications. Dental Implants may be placed immediately and put into immediate function providing that the initial stability requirements detailed in the surgical manuals are satisfied.. Recalled by Nobel Biocare Usa Llc. Units affected: 74 units.
Why was this product recalled? ▼
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 first threads.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 22, 2015. Severity: Moderate. Recall number: Z-1420-2015.

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