Z-1565-2022Class II

Nobel Biocare N1 TiUltra TCC NP 3.5x13mm

Name: Z-1565-2022 Nobel Biocare N1 TiUltra TCC NP 3.5x13mm
Creator: Nobel Biocare
Published: 2022-07-25
License: https://open.fda.gov/license/

Nobel Biocare AB / initiated 2022-07-25 / Open, Classified

FDA source

Nobel Biocare began a recall of Nobel Biocare N1 TiUltra TCC NP 3.5x13mm on 2022-07-25. FDA classified it as Class II and gives the reason as "Due to the presence of a burr which may cause an aspiration risk to patient during surgical procedure". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-1565-2022
Classification: Class II
Status: Open, Classified
Initiated: 2022-07-25
Posted: 2022-08-23
Recalling firm: Nobel Biocare AB
Product: Nobel Biocare N1 TiUltra TCC NP 3.5x13mm
Product code: DZE Implant, Endosseous, Root-Form
Reason for recall: Due to the presence of a burr which may cause an aspiration risk to patient during surgical procedure.
FDA root cause: Process change control
Action: On 07/25/2022, Nobel Biocare AB sent an "URGENT MEDICAL DEVICE RECALL" Letter via UPS to customers informing them that there may be a burr present on the co-packed OsseoShaper 1 around the waist of the device. The hazard is primarily identified as a risk of the patient swallowing or inhaling the burr if it comes loose from the OsseoShaper 1 during the clinical procedure. Customer are instructed to: 1. Inspect their stock and quarantine affected devices. 2. Complete attached Customer Acknowledgment Form, even if they do not have any affected stock, and return it to Nobel Biocare, via email to [email protected] or fax 714-282-5073 within 5 days of receipt of this notice. 3. Return all affected stock on hand to Nobel Biocare using the shipping label attached to this notice. 4. Ensure relevant staff members are informed of this recall. If they have supplied or transferred any potentially affected product to another facility or organization, let that facility know of the recall by providing a copy of this notice. Nobel Biocare has implemented preventive actions and will replace devices subject to this recall free of charge. For questions - contact local customer support representative at 800-322-5001 ext. 1527.
Quantity in commerce: 347 devices
Distribution: U.S Nationwide.: AZ, CA, CT, FL, HI, NC, NY, OR, PA, TX, UT, and WI O.U.S.: Austria, Belgium, Canada, Germany, Spain, France, United Kingdom, Hungary, Iceland, Italy, Netherlands, Norway, Portugal, and Sweden
Product codes and lots: Catalog number: 300859 Lot numbers / UDI Codes: 12167337 / (01)07332747161717(10)12167337(11)210119(17)251218 12167830 / (01)07332747161717(10)12167830(11)210125(17)251224 12168184 / (01)07332747161717(10)12168184(11)210128(17)251227

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1565-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1565-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-08-31	2022-08-23

Product code DZE

K211109Class IIN1 TiUltra TCC Implant SystemNobel Biocare Services AG / cleared 2021-12-21

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)