# FDA recall Z-1680-2021

> **Nobel Biocare Procera LLC** · Class II · device recall initiated 2021-03-29.

## Product

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

## Reason for recall

Not manufactured to specification

## Distribution

Worldwide distribution - US Nationwide distribution in the states of AL,CA, OK, WA and the countries of Belgium, Canada,  Italy, Sweden, Switzerland.

## Key facts

- **Recall number:** Z-1680-2021
- **Recalling firm:** Nobel Biocare Procera LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2021-03-29
- **Report date:** 2021-06-02
- **Termination date:** 2021-09-01

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Mahwah, NJ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1680-2021

## Citation

> AI Analytics. FDA recall Z-1680-2021. Retrieved 2026-06-10 from https://api.ai-analytics.org/recall/Z-1680-2021. Source: US FDA. Licensed CC0.

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