Nobel Biocare: Device Recall
Recall #Z-1101-2025 · 01/10/2025
Class II: Risk
Recall Details
- Recall Number
- Z-1101-2025
- Classification
- Class II
- Product Type
- Device
- Recalling Firm
- Nobel Biocare
- Status
- Ongoing
- Date Initiated
- 01/10/2025
- Location
- Goteborg, Sweden
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1,558 units (90 units - U.S.)
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.
Product Description
. 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
Distribution Pattern
U.S. Nationwide distribution in the states of CA, FL, IL, MA, NJ, NY, OH, PA, UT, VA and WA.
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.