Z-2762-2026 Class II Ongoing
FDA device recall Z-2762-2026 was initiated by SEASPINE ORTHOPEDICS CORPORATION on May 28, 2026 and is designated Class II. Reason for recall: Due to manufacturing error, polyaxial head may popoff from the screw intraoperatively following insertion. The recall status is ongoing. Affected quantity: 796 units.
Recall Details
- Product Type
- Devices
- Report Date
- July 29, 2026
- Initiation Date
- May 28, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 796 units
Product Description
SeaSpine Polyaxial Head REF Number: 41-3010
Reason for Recall
Due to manufacturing error, polyaxial head may popoff from the screw intraoperatively following insertion.
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.
Code Information
UDI: 10889981155117; Affected Lots: AW199682G, AW199684G.