FDA Device recall Z-1678-2021
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…
- FDA Device
- Class II
- terminated
- Published 2021-06-02
On 2021-06-02 the FDA classified a Class II recall of 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… by Nobel Biocare Procera, citing not manufactured to specification.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1678-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2021-03-29 |
| Published | 2021-06-02 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Nobel Biocare Procera |
| Distribution | US |
Product
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
Not manufactured to specification
Identifiers
| code_info | Serial Numbers: 173939852, 173940027, 173940107, 173940346, 173940844, 173940852, 173942662 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1678-2021%22
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