Recall Z-1565-2022 ยท DZE Implant, Endosseous, Root-Form
Nobel Biocare
Nobel Biocare N1 TiUltra TCC NP 3.5x13mm
| Date | Aug 23, 2022 (initiated Jul 25, 2022) |
| Status | Open, Classified |
| Reason | Due to the presence of a burr which may cause an aspiration risk to patient during surgical procedure. |
| Root cause | Process change control |
| Action | On 07/25/2022, Nobel Biocare AB sent an "URGENT MEDICAL DEVICE RECALL" Letter via UPS to customers informing them that there may be a burr present on the co-packed OsseoShaper 1 around the waist of the device. The hazard is primarily identified as a risk of the patient swallowing or inhaling the burr if it comes loose from the OsseoShaper 1 during the clinical procedure. Customer are instructed to: 1. Inspect their stock and quarantine affected devices. 2. Complete attached Customer Acknowledgment Form, even if they do not have any affected stock, and return it to Nobel Biocare, via email to |
| Quantity | 347 devices |
| Distribution | U.S Nationwide.: AZ, CA, CT, FL, HI, NC, NY, OR, PA, TX, UT, and WI O.U.S.: Austria, Belgium, Canada, Germany, Spain, France, United Kingdom, Hungary, Iceland, Italy, Netherlands, Norway, Portugal, and Sweden |
| 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 |