United StatesSeaSpine Polyaxial Head (REF 41-3010; UDI 10889981155117), lots AW199682G and AW199684G (796 units), distributed worldwide including the listed U.S. states, Chile and Australia, is affected. It was recalled because a manufacturing error can cause the polyaxial head to pop off from the screw intraoperatively following insertion.
What's being recalled
SeaSpine Polyaxial Head REF Number: 41-3010
Recalling firm: Seaspine Orthopedics Corporation, Carlsbad, CA, United States.
How to identify it
UDI: 10889981155117; Affected Lots: AW199682G, AW199684G.
The hazard
Due to manufacturing error, polyaxial head may popoff from the screw intraoperatively following insertion.
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
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.
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)