Recall Z-3226-2026 ยท NKB Thoracolumbosacral Pedicle Screw System
SEASPINE ORTHOPEDICS CORPORATION
SeaSpine Mariner Deformity Product Name: Extended Polyaxial Head, Attached Gimbal, 12mm REF: MD1-300010-12
| Date | Sep 18, 2026 (initiated Aug 19, 2026) |
| Status | Open, Classified |
| Reason | The proximal thread depth of the spinal device is out of design specification. |
| Root cause | Process design |
| Action | On August 19, 2026, SeaSpine Orthopedics Corporation a subsidiary Orthofix issued a Urgent Medical Device Recall Notification via Email. SeaSpine ask consignees to take the following actions: Actions to be taken by the Customer/User: 1Discontinue use of affected lots 2Immediately identify and quarantine any affected product 3. If product is identified, Orthofix will facilitate the return 4.Complete and return the attached Acknowledgement and Receipt Form 5.This recall notice should be shared with anyone who needs to be aware within your organization and forwarded to any organization where p |
| Quantity | 270 units |
| Distribution | US Nationwide distribution in the states of Alabama, California, Colorado, Connecticut, Florida, Georgia, Massachusetts, Michigan, Minnesota, Missouri, North Carolina, Nevada, New York, Oklahoma, Oregon, Tennessee, Texas, and Virginia. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K211606 | Mariner Deformity System SeaSpine Orthopedics Corporation, Jun 23, 2021 |