- Recalling firm
- SEASPINE ORTHOPEDICS CORPORATION
- Reason for recall
- Due to manufacturing error, polyaxial head may popoff from the screw intraoperatively following insertion.
- Affected products (lot / model / serial)
- UDI: 10889981155117; Affected Lots: AW199682G, AW199684G.
- Units affected
- 796 units
- Distribution pattern
- 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, Washington, and Wyoming. The countries of Chile and Australia.
- Firm location
- Carlsbad, CA, United States
- Recall type
- Voluntary: Firm initiated
- How the firm notified customers
- N/A
- Product type
- Devices
- Status
- Ongoing
- Recall number
- Z-2762-2026
- Recall initiated
- May 28, 2026
- FDA classification date
- July 20, 2026
- FDA report date
- July 29, 2026
- FDA event ID
- 99221
- Last updated on HTM Vibe
- August 4, 2026