Class 2 Device Recall Nobel Biocare N1 TiUltra TCC RP

• Date Initiated by Firm: January 10, 2025
• Date Posted: February 05, 2025
• Recall Status: Open, Classified
• Recall Number: Z-1101-2025
• Recall Event ID: 96047
• 510(K)Number: K211109
• Product Classification: Implant, endosseous, root-form - Product Code DZE
• 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
• Code Information: 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
• Recalling Firm/ Manufacturer: Nobel Biocare; Vastra Hamngatan 1; Goteborg Sweden
• Manufacturer 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.
• FDA Determined 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 us.cs.complaints@nobelbiocare.com 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 us.cs.complaints@nobelbiocare.com, 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 us.cs.complaints@nobelbiocare.com
• 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = DZE