FDA Medical Device Recalls (openFDA)
Nobel Biocare Procera LLC: NPr FCZImp 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
- Recall number
- Z-1680-2021
- Recalling firm
- Nobel Biocare Procera LLC
- Product
- NPr FCZImp 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
- Status
- Terminated
- Initiated
- 2021-03-29
- Posted
- not on file
- Terminated
- 2021-09-01
- Reason
- Not manufactured to specification
- 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
- 1 unit
- Distribution
- Worldwide distribution - US Nationwide distribution in the states of AL,CA, OK, WA and the countries of Belgium, Canada, Italy, Sweden, Switzerland.
- Lot, serial or model codes
- Serial Numbers: 173943753
- 510(k) numbers
- ["K132746"]
- PMA numbers
- not on file
- Product code
- NHA
- Firm FEI
- 3005031178
- Firm city
- Mahwah
- Firm state
- NJ
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28