Unrated Medical device recall · FDA · Published March 29, 2021

Nobel Biocare Implant Crown Recall: Not Manufactured to Specification

Nobel Biocare recalls implant crowns not manufactured to specification. Affected units have material number 77364 and serial numbers starting with 173943753. Consumers should contact the manufacturer for details.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-1680-2021Medical device Nobel Biocare ›

Recall notice

Not manufactured to specification

Take action

Contact the company

Recalling firmNobel Biocare Procera LLC800 Corporate Dr · Mahwah, NJ 07430-2011

✎ GovInfoNow plain-language explainer

Nobel Bioc: Recalls implant crowns that were not made to the correct specifications. This could lead to improper fit or function in the jaw, potentially causing discomfort or complications during chewing. Read more at govinfonow.com/recall/62888-nobel-biocare-implant-crown-recall-not-manufactured-to-specification.

Source Summary by GovInfoNow · govinfonow.com/recall/62888-nobel-biocare-implant-crown-recall-not-manufactured-to-specification · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1680-2021

Cite this page

“Nobel Biocare Implant Crown Recall: Not Manufactured to Specification.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/62888-nobel-biocare-implant-crown-recall-not-manufactured-to-specification. Based on FDA recall #Z-1680-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1680-2021%22&limit=1).

Nobel Biocare Procera LLC recalled one NPr FCZ¿Imp Crwn ASC CC RP CAD 1-25¿ s4 implant crown on March 29, 2021, because it was not manufactured to specification, the FDA said. The product is intended for use in the upper or lower jaw.

How to tell if you have it

Brand: Nobel Biocare
Product: NPr FCZ¿Imp Crwn ASC CC RP CAD 1-25¿ s4
Material Number: 77364
Serial Number: 173943753

The hazard

The implant crown was not manufactured to specification, creating a prosthetic device intended to restore chewing function and esthetics.

Context

GovInfoNow's records show Nobel Biocare has other recent recalls of similar products include Straumann GM Helix Dental Implant Recall: Packaging Mismatch Risk (2026-07-13), Bard Soft Tissue Biopsy Trays Recall: Lidocaine Ampoule Manufacturing Deficiency (2026-05-21) and Straumann Dental Implant Abutments Recall: Incorrect Screw Seat Interface Hazard (2026-03-27).

How to tell if you have this one

Check for material number 77364 and serial numbers starting with 173943753 on the product. The crowns are used for jaw restoration and are part of a prosthetic device.

Brand
Nobel Biocare
Category
Medical device

FDA recall event · 5 products

All 5 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

Classification
Class II
Status
Terminated
Distribution
Worldwide distribution - US Nationwide distribution in the states of AL,CA, OK, WA and the countries of Belgium, Canada, Italy, Sweden, Switzerland.

Recall number	Product, codes & lots	Quantity
Z-1677-2021	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; Serial Numbers: 173943674, 173943711	2 units
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 device (full contour crown), and to restore the patient s chewing function and esthetics. Material Number: 77352; Serial Numbers: 173939852, 173940027, 173940107, 173940346, 173940844, 173940852, 173942662	7 units
Z-1679-2021	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; Serial Numbers: 173940845	1 unit
Z-1680-2021	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; Serial Numbers: 173943753	1 unit
Z-1681-2021	NPr FCZ¿Imp Crwn ASC CC NP CAD 1-25¿ s6 - 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: 77387; Serial Numbers: 173942675	N/A

Based on the official FDA remedy

What to do — step by step

Contact Manufacturer
Reach out to Nobel Biocare Procera LLC for specific instructions on how to handle the recalled product.

Where it went and when

Where it was distributed

Distributed nationwide and abroad; the notice names 4 states.

FDA distribution: “Worldwide distribution - US Nationwide distribution in the states of AL,CA, OK, WA and the countries of Belgium, Canada, Italy, Sweden, Switzerland.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: Alabama, California, Oklahoma, Washington.

Recall timeline

FDA terminated this recall 5 months after the firm started it.

Mar 29, 2021Firm started the recall
May 25, 2021FDA classified it Class II
Jun 2, 2021Published in FDA’s Enforcement Report
Sep 1, 2021FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/62888-nobel-biocare-implant-crown-recall-not-manufactured-to-specification">Nobel Biocare Implant Crown Recall: Not Manufactured to Specification (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-1680-2021 (March 29, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1680-2021 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.