Z-1677-2021Class II

NPr FCZImp Crwn ASC CC RP CAD 1-25 s2 -

Name: Z-1677-2021 NPr FCZImp Crwn ASC CC RP CAD 1-25 s2 -
Creator: Nobel Biocare Procera LLC
Published: 2021-03-29
License: https://open.fda.gov/license/

Nobel Biocare Procera LLC / initiated 2021-03-29 / Terminated / root cause: manufacturing process

FDA source

Nobel Biocare Procera LLC began a recall of NPr FCZImp 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... on 2021-03-29. FDA classified it as Class II and gives the reason as "Not manufactured to specification". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1677-2021
Classification: Class II
Status: Terminated
Initiated: 2021-03-29
Posted: 2021-05-25
Terminated: 2021-09-01
Recalling firm: Nobel Biocare Procera LLC
Product: NPr FCZImp 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
Product code: NHA Abutment, Implant, Dental, Endosseous
Reason for recall: Not manufactured to specification
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Nobel Dental notified US customers via phone by North American Customer Service on 3/29/21 and informed which device[s] was affected and that the device[s] had not been processed properly. Email communication was also distributed with a return label. Please find attached the return label for order XXXX to be returned to our manufacturing facility. We sincerely apologize for the inconvenience that this delay has caused. With the new order we are taking all possible actions to have it to you as soon as possible, while still ensuring the premium quality that you expect. The EMEA customer service/sales representatives were contacted by North America Customer Service.
Quantity in commerce: 2 units
Distribution: Worldwide distribution - US Nationwide distribution in the states of AL,CA, OK, WA and the countries of Belgium, Canada, Italy, Sweden, Switzerland.
Product codes and lots: Serial Numbers: 173943674, 173943711

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1677-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1677-2021	Class II	Terminated	Voluntary: Firm initiated	2021-06-02	2021-05-25
Z-1678-2021	Class II	Terminated	Voluntary: Firm initiated	2021-06-02	2021-05-25
Z-1679-2021	Class II	Terminated	Voluntary: Firm initiated	2021-06-02	2021-05-25
Z-1680-2021	Class II	Terminated	Voluntary: Firm initiated	2021-06-02	2021-05-25
Z-1681-2021	Class II	Terminated	Voluntary: Firm initiated	2021-06-02	2021-05-25

Product code NHA

K132746Class IINobelprocera Angulated Screw Channel Abutment Conical ConnectionNobel Biocare USA, LLC / cleared 2014-01-30

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)