Recall Z-2762-2026 ยท NKB Thoracolumbosacral Pedicle Screw System
SEASPINE ORTHOPEDICS CORPORATION
SeaSpine Polyaxial Head REF Number: 41-3010
| Date | Jul 20, 2026 (initiated May 28, 2026) |
| Status | Open, Classified |
| Reason | Due to manufacturing error, polyaxial head may popoff from the screw intraoperatively following insertion. |
| Root cause | Process change control |
| Action | On June 16, 2026, Orthofix issued a updated Urgent Medical Device Recall notification to provide additional information concerning the recall. Initial notification was issued on May 28, 206. Orthofix ask consignees to take the following actions: 1. Discontinue use of affected lots, 2.Immediately 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 an |
| Quantity | 796 units |
| Distribution | Worldwide - US Nationwide distribution including in the states of Alabama, Arizona, California, Colorado, Connecticut, Florida, Illinois, Indiana, Kansas, Maryland, Michigan, Missouri, Mississippi, Montana, Nevada, Ohio, Oklahoma, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washi |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K173882 | SeaSpine Mariner Pedicle Screw System SeaSpine Orthopedics Corporation, Feb 6, 2018 |