SeaSpine Polyaxial Head spinal implant recalled for intraoperative detachment risk
SeaSpine Orthopedics has recalled certain Polyaxial Head spinal implants (REF 41-3010) due to a manufacturing error that may cause the polyaxial head to detach from the screw during surgery after insertion. This could require additional surgical intervention. The recall affects 796 units distributed worldwide, including nationwide US distribution and locations in Chile and Australia.
From the FDA notice · Read the official notice ↗ · All SeaSpine recalls
What to do
- If you are a surgeon or facility that has used this product, contact SeaSpine Orthopedics immediately for guidance on affected lot numbers AW199682G and AW199684G.
- Review your inventory for the affected lot numbers using the UDI: 10889981155117.
- For patients who may have received this implant, consult your surgeon about your specific situation.
Is yours affected?
Compare your label or packaging with the recalled product.
- Product
- SeaSpine Polyaxial Head REF Number: 41-3010
- Sold in
- Nationwide
- Made for
- All ages
Details
- Units affected
- 796 units
- Illnesses reported
- None reported
- Manufactured in
- 5770 Armada Dr, N/A, Carlsbad, CA, United States
- Classification
- Class II
- Recall number
- Z-2762-2026
In the FDA's words
- Description
- SeaSpine Polyaxial Head REF Number: 41-3010 Due to manufacturing error, polyaxial head may popoff from the screw intraoperatively following insertion. UDI: 10889981155117; Affected Lots: AW199682G, AW199684G. 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, Washington, and Wyoming. The countries of Chile and Australia. Affected quantity: 796 units
- Hazard
- Due to manufacturing error, polyaxial head may popoff from the screw intraoperatively following insertion.
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ModerateFDASep 30, 2026