Z-1678-2021 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- June 2, 2021
- Initiation Date
- March 29, 2021
- Termination Date
- September 1, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 7 units
Product Description
NPr FCZ¿Imp Crwn ASC CC RP CAD 1-25¿s3 - 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: 77352
Reason for Recall
Not manufactured to specification
Distribution Pattern
Worldwide distribution - US Nationwide distribution in the states of AL,CA, OK, WA and the countries of Belgium, Canada, Italy, Sweden, Switzerland.
Code Information
Serial Numbers: 173939852, 173940027, 173940107, 173940346, 173940844, 173940852, 173942662