Z-1101-2025Class II

. Nobel Biocare N1 TiUltra TCC RP 4.0x9mm . Nobel Biocare N1 TiUltra TCC RP 4.0x11mm . Nobel Biocare N1...

Name: Z-1101-2025 . Nobel Biocare N1 TiUltra TCC RP 4.0x9mm . Nobel Biocare N1 TiUltra TCC RP 4.0x11mm . Nobel Biocare N1...
Creator: Nobel Biocare
Published: 2025-01-10
License: https://open.fda.gov/license/

Nobel Biocare AB / initiated 2025-01-10 / Open, Classified / root cause: manufacturing process

FDA source

Nobel Biocare began a recall of . Nobel Biocare N1 TiUltra TCC RP 4.0x9mm . Nobel Biocare N1 TiUltra TCC RP 4.0x11mm . Nobel Biocare N1 TiUltra TCC RP 4.0x13mm Nobel Biocare N1 TiUltra TCC... on 2025-01-10. FDA classified it as Class II and gives the reason as "Due to manufacturing issue (unintended by-product of the injection molding process) a sharp pin that may puncture the blister packaging and breaching the sterile barrier of the finished product". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1101-2025
Classification: Class II
Status: Open, Classified
Initiated: 2025-01-10
Posted: 2025-02-05
Recalling firm: Nobel Biocare AB
Product: . Nobel Biocare N1 TiUltra TCC RP 4.0x9mm . Nobel Biocare N1 TiUltra TCC RP 4.0x11mm . Nobel Biocare N1 TiUltra TCC RP 4.0x13mm Nobel Biocare N1 TiUltra TCC implants are intended for use as an endosseous dental implant in the maxilla or mandible for anchoring or supporting dental protheses to restore chewing function
Product code: DZE Implant, Endosseous, Root-Form
Reason for recall: Due to manufacturing issue (unintended by-product of the injection molding process) a sharp pin that may puncture the blister packaging and breaching the sterile barrier of the finished product.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: On 01/10/2025, the firm emailed an "URGENT MEDICAL DEVICE RECALL" Letter to customers informing them that Nobel Biocare became aware through internal quality control one of the plastic components of the packaging that is used to hold the OsseoShaper in place may contain a manufacturing error. This results in a sharp edge that could puncture the blister packaging, thereby breaching the sterile barrier. Customers and Distributors are instructed to: 1. Inspect their stock and quarantine affected devices. The use of affected devices should be ceased immediately. 2. For Distributors, complete attached Distributor Acknowledgement Form with information collected from end user and return the firm to Nobel Biocare via email to [email protected] with in 5 days of receipt of this notice. 2. Complete attached Customer Acknowledgment Form, even if customers do not have any affected stock, and return it to Nobel Biocare, via email to [email protected], 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 products were supplied or transferred to another facility or organization, inform these facilities of the recall by providing a copy of this notice. For question or further support, contact local customer support representative at 800-322-5001 ext. 1527 or at [email protected]
Quantity in commerce: 1,558 units (90 units - U.S.)
Distribution: U.S. Nationwide distribution in the states of CA, FL, IL, MA, NJ, NY, OH, PA, UT, VA and WA.
Product codes and lots: Nobel Biocare N1 TiUltra TCC RP 4.0x 9mm Catalog Number: 300861 UDI-DI code: 07332747161731 Lot Numbers: 12253672 12253673 Nobel Biocare N1 TiUltra TCC RP 4.0x11mm Catalog Number: 300862 UDI-DI code: 07332747161748 Lot Numbers: 12253448 12254209 Nobel Biocare N1 TiUltra TCC RP 4.0x13mm Catalog Number: 300863 UDI-DI code: 07332747161755 Lot Numbers: 12253620 12254213

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1101-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1101-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-02-12	2025-02-05

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)