TemporaryFDAOngoing
Can make you unwell for a while. Do not eat it.
SeaSpine Polyaxial Head REF Number: 41-3010
Check your package for
UDI: 10889981155117; Affected Lots: AW199682G, AW199684G.
- Why
- Due to manufacturing error, polyaxial head may popoff from the screw intraoperatively following insertion.
- Distributed
- 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.
- Company
- SEASPINE ORTHOPEDICS CORPORATION
- Announced
- Recall began