SeaSpine Polyaxial Head REF Number: 41-3010
FDA device recall Z-2762-2026 · posted 2026-07-20 · Open, Classified
Recall details
- Recalling firm
- SEASPINE ORTHOPEDICS CORPORATION
- Reason for recall
- Due to manufacturing error, polyaxial head may popoff from the screw intraoperatively following insertion.
- Action taken
- 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 any organization where potentially affected devices have been transferred.
- Root cause
- Process change control
- Status
- Open, Classified
- Product code
- NKB
- Quantity affected
- 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, Mo
- Date initiated
- 2026-05-28
- Date posted
- 2026-07-20
- Location
- Carlsbad, CA
Monitor recalls programmatically
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| SeaSpine Mariner Pedicle Screw System (K173882) | SeaSpine Orthopedics Corporation | 2018-02-06 |