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

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.

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

• FDA enforcement recordOfficial FDA database entry for Z-1101-2025
• FDA 510(k) clearance · K211109The device's official FDA premarket clearance record
• FDA device classification · DZEOfficial FDA classification for this device type
• CFR regulation · 21 CFR 872.3640The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Nobel BiocareSearch for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.