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Nobel Biocare Procera LLC Recall 87848

Description: 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

Nobel Biocare Procera LLC Recall 87848 Information

StatusTerminated
Mandated?Voluntary: Firm initiated
Recall NumberZ-1680-2021
Event ID87848
Event DescriptionNPr 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
Product TypeDevices
DistributionWorldwide distribution - US Nationwide distribution in the states of AL,CA, OK, WA and the countries of Belgium, Canada, Italy, Sweden, Switzerland.
Quantity1 unit
Recall ReasonNot manufactured to specification
Device Classification20210602
Device Code InfoSerial Numbers: 173943753
Center Classification Date20210525
Recall Initiation Date20210329
Recalling FirmNobel Biocare Procera LLC
Initial Notification Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
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