Data Foundry

Medical device recalls 2021

NPr FCZ¿Imp Crwn ASC CC NP CAD 1-25¿ s4 — Class II medical device recall Z-1679-2021

Terminated recall by Nobel Biocare Procera LLC, reported 2021-06-02, distributed nationwide. Not manufactured to specification

Recall numberZ-1679-2021
Product typeMedical device
ClassificationClass II
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmNobel Biocare Procera LLC, Mahwah, NJ, United States
Recall initiated2021-03-29
Classified2021-05-25
Reported by FDA2021-06-02
Terminated2021-09-01
DistributedNationwide (US)
Countries outside the USBE, CA, CH, IT, SE
Quantity1 units
Serial numbers173940845

Product

NPr FCZ¿Imp Crwn ASC CC NP 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: 77363

Reason for recall

Not manufactured to specification

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1679-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.