CLASS II Device recall · Reported 2 Jun 2021 · FDA Enforcement Report

NPr FCZ¿Imp Crwn ASC CC RP CAD 1-25¿ s2 recalled

Nobel Biocare Procera is recalling NPr FCZ¿Imp Crwn ASC CC RP CAD 1-25¿ s2, distributed nationwide in the US. The recall was initiated on 29 Mar 2021 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesSerial Numbers: 173943674, 173943711

Quantity recalled2 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1677-2021
FDA event ID: 87848
Recalling firm: Nobel Biocare Procera, Mahwah, NJ
Classification: Class II
Status: Terminated
Recall initiated: 29 Mar 2021
FDA classified: 25 May 2021
Reported: 2 Jun 2021
Type: Voluntary: Firm initiated
Customers notified by: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Reason category: Other Reasons
Device type: Masks, Gloves & PPE

Timeline

29 Mar 2021	Recall initiated by company
25 May 2021	Classified by FDA	+57 days
2 Jun 2021	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Not manufactured to specification

Product as listed by the FDA

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

Where it was distributed

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

Nationwide Alabama California Oklahoma Washington

Questions about this recall

Why was it recalled?

Not manufactured to specification

Which lots are affected?

Serial Numbers: 173943674, 173943711

Where was it sold?

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

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

4 other products · FDA event 87848

This product is part of a recall event; the main page for the event is NPr FCZ¿Imp Crwn ASC CC RP CAD 1-25¿ s4 recalled.

Reported	Class	Recall	Company	Reason	Where
2 Jun 2021	CLASS II	NPr FCZ¿Imp Crwn ASC CC RP CAD 1-25¿ s4 recalled	Nobel Biocare Procera	Other	Nationwide
2 Jun 2021	CLASS II	NPr FCZ¿Imp Crwn ASC CC NP CAD 1-25¿ s4 recalled	Nobel Biocare Procera	Other	Nationwide
2 Jun 2021	CLASS II	NPr FCZ¿Imp Crwn ASC CC RP CAD 1-25¿s3 recalled	Nobel Biocare Procera	Other	Nationwide
2 Jun 2021	CLASS II	NPr FCZ¿Imp Crwn ASC CC NP CAD 1-25¿ s6 recalled	Nobel Biocare Procera	Other	Nationwide

More recalls from Nobel Biocare Procera

All 5

Reported	Class	Recall	Company	Reason	Where
2 Jun 2021Device	CLASS II	NPr FCZ¿Imp Crwn ASC CC NP CAD 1-25¿ s6 recalled	Nobel Biocare Procera	Other	Nationwide
2 Jun 2021Device	CLASS II	NPr FCZ¿Imp Crwn ASC CC RP CAD 1-25¿s3 recalled	Nobel Biocare Procera	Other	Nationwide
2 Jun 2021Device	CLASS II	NPr FCZ¿Imp Crwn ASC CC NP CAD 1-25¿ s4 recalled	Nobel Biocare Procera	Other	Nationwide
2 Jun 2021Device	CLASS II	NPr FCZ¿Imp Crwn ASC CC RP CAD 1-25¿ s4 recalled	Nobel Biocare Procera	Other	Nationwide

Other Masks, Gloves & PPE recalls

All 447

Reported	Class	Recall	Company	Reason	Where
29 Jul 2026Device	CLASS II	P28 Phanton Intramedullary Nail System recalled by Paragon 28	Paragon 28	Sterility	Nationwide
8 Jul 2026Device	CLASS II	Cyberknife Treatment Deliver System equipped recalled	Accuray	Device Malfunction	Nationwide
8 Jul 2026Device	CLASS II	Adapter for Head Positioning recalled by Baxter Healthcare	Baxter Healthcare	Other	Nationwide
8 Jul 2026Device	CLASS II	Cyberknife Treatment Deliver System equipped recalled	Accuray	Device Malfunction	Nationwide
3 Jun 2026Device	CLASS II	Halyard Purezero Ultraviolet Nitrile Exam Gloves Reference recalled	O&M Halyard	Other	Nationwide