FDA recall Z-2762-2026

Product

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

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.

Key facts

Status

Ongoing

Initiation date

2026-05-28

Report date

2026-07-29

Voluntary/Mandated

Voluntary: Firm initiated

Location

Carlsbad, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2762-2026