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

Hazard

Due to manufacturing error, polyaxial head may popoff from the screw intraoperatively following insertion.

Details from the source

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. Quantity: 796 units Lot/code info: UDI: 10889981155117; Affected Lots: AW199682G, AW199684G.

UPC codes

10889981155117

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.