Recall Z-1101-2025 ยท DZE Implant, Endosseous, Root-Form
Nobel Biocare
. 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
| Date | Feb 5, 2025 (initiated Jan 10, 2025) |
| Status | Open, Classified |
| Reason | 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 | 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 atta |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K211109 | N1 TiUltra TCC Implant System Nobel Biocare Services AG, Dec 21, 2021 |