Device product
NPr FCZ¿Imp Crwn ASC CC RP CAD 1-25¿ s2 - 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: 77339
Z-1677-2021
Product summary
- Event
- Event 87848
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2 units
- Official record key
device-enforcement:Z-1677-2021
Official wording
Reason: Not manufactured to specification
Code information: Serial Numbers: 173943674, 173943711
Distribution pattern: Worldwide distribution - US Nationwide distribution in the states of AL,CA, OK, WA and the countries of Belgium, Canada, Italy, Sweden, Switzerland.
Derived failure modes
-
Unknown
Not manufactured to specification