SeaSpine Polyaxial Head REF Number: 41-3010 recall (SEASPINE ORTHOPEDICS CORPORATION)
Medical deviceClass IIOngoing
Summary: SEASPINE ORTHOPEDICS CORPORATION is recalling SeaSpine Polyaxial Head REF Number: 41-3010. Reason: Due to manufacturing error, polyaxial head may popoff from the screw intraoperatively following insertion.
What is being recalled
SeaSpine Polyaxial Head REF Number: 41-3010
Why
Due to manufacturing error, polyaxial head may popoff from the screw intraoperatively following insertion.
How serious is it
Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.
Where it was sold
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. (states named: 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, Wyoming)
How to tell if yours is affected
UDI: 10889981155117; Affected Lots: AW199682G, AW199684G.
What to do
Check the model, lot or serial numbers above against your device. If yours is affected, contact the manufacturer or your healthcare provider before you stop using a device you rely on.
Recall facts
| Recall number | Z-2762-2026 |
| Category | Medical device |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class II |
| Status | Ongoing |
| Recall started | May 28, 2026 |
| Reported | July 29, 2026 |
| Company | SEASPINE ORTHOPEDICS CORPORATION |
| Company location | Carlsbad, CA, United States |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 796 units |
More recalls from SEASPINE ORTHOPEDICS CORPORATION · all medical device recalls · recalls from May 2026