FDAFDA · Food and drugs·Recall number Z-1428-2015
NobelReplace CC RP 4.3x8mm, Article No. 36704.
Published April 22, 2015 · Recall initiated: March 9, 2015
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Nobel Biocare Usa Llc
- Distributor
- 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.
- Lot
- Batch No. 13011378, 13011379, 13011664.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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