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Class IIOngoing

SEASPINE ORTHOPEDICS CORPORATION recalls SeaSpine Polyaxial Head REF Number: 41-3010

Recall date · record updated Jul 29, 2026 · Source: U.S. Food and Drug Administration (openFDA device enforcement)

What to do

Check your product against the names and codes above. The FDA enforcement record lists the recall as voluntary: firm initiated; it does not state a consumer remedy, so follow the firm’s notice or the FDA link.

Company
SEASPINE ORTHOPEDICS CORPORATION
Reason
Due to manufacturing error, polyaxial head may popoff from the screw intraoperatively following insertion.
Hazard
FDA Class II: may cause temporary or medically reversible adverse health consequences (FDA definition).
Who’s affected
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.
Where
Nationwide
Official notice
www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99221…

Products

  1. SeaSpine Polyaxial Head REF Number: 41-3010

    Codes/lots: UDI: 10889981155117; Affected Lots: AW199682G, AW199684G.Quantity: 796 unitsRecall no. Z-2762-2026Class II

Update history

  1. First listed on OVERLOOKED from the official record.

When the agency expands or changes this recall, we update this page and log the change here.

Proof: raw official record (JSON) · fetched from FDA API

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