RegWardenFDA facility compliance records
Recall

Class II — Nobel Biocare Procera LLC

Recalling firmNobel Biocare Services AG
Registered facilityView this company's 7 registered facilities → (openFDA recall records do not name a specific facility)
ClassificationClass II
StatusTerminated
ReasonNot manufactured to specification
ProductNPr FCZImp 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
Quantity1 unit
DistributionWorldwide distribution - US Nationwide distribution in the states of AL,CA, OK, WA and the countries of Belgium, Canada, Italy, Sweden, Switzerland.
Initiated2021-03-29
Classified2021-05-25
Terminated2021-09-01
Recall numberZ-1679-2021
InitiationVoluntary: Firm initiated

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)

Cite this record

RegWarden. “Class II recall — Nobel Biocare Procera LLC (Z-1679-2021).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/87848/

Not open yet

Alerts for Nobel Biocare Services AG

Watchlist alerts will email you when FDA publishes a new recall, inspection classification, or warning letter for a facility you follow. They aren't open to the public yet — leave your email and we'll tell you when they are.

Planned

Want a one-page facility brief?

A single-page summary of this facility's registration and recall history for diligence. Not selling it yet — register interest and we'll follow up.