FDA-Device2026-07-29Class IIPROCESSING DEFECT
SeaSpine Polyaxial Head spinal implant recalled for intraoperative detachment risk
OTHERNationwide distribution
SeaSpine Polyaxial Head recalled for potential intraoperative pop-off
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.
- 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.
Hazard
Due to manufacturing error, polyaxial head may popoff from the screw intraoperatively following insertion.
Sold states
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 count
796 units
Manufactured in
5770 Armada Dr, N/A, Carlsbad, CA, United States
Products
SeaSpine Polyaxial Head REF Number: 41-3010
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2762-2026Don't want to check this manually?
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