FDAFDA · Food and drugs·Recall number Z-1680-2021
NPr FCZ¿Imp Crwn ASC CC RP CAD 1-25¿ s4 - Product Usage: Implant Crown intended to be placed in the upper or lower jaw creating a prosthetic device (full contour crown), and to restore the patient s chewing function and esthetics. Material Number: 77364
Published June 2, 2021 · Recall initiated: March 29, 2021
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
Not manufactured to specification
What to do
Voluntary: Firm initiated · Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recall details
- Manufacturer
- Nobel Biocare Procera LLC
- Distributor
- Worldwide distribution - US Nationwide distribution in the states of AL,CA, OK, WA and the countries of Belgium, Canada, Italy, Sweden, Switzerland.
- Lot
- Serial Numbers: 173943753
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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