FDAFDA · Food and drugs·Recall number Z-1666-2013
InSpan Inserter, Right Assembly; InSpan Inserter, Left Assembly Product Usage: Inserters are stainless steel instruments that have an inner shaft. The left and right inserters are used in combination with each other to place the implants into the body. Inserters are used to install the InSpan Spinous Plate System for the purpose of achieving supplemental fixation.
Published July 10, 2013 · Recall initiated: May 7, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Potential for set screw to be come deformed.
What to do
Voluntary: Firm initiated
Recall details
- Manufacturer
- SpineFrontier, Inc.
- Distributor
- Worldwide Distribution - USA Nationwide: in the states of: FL, CO, VA, KS, TX, OH, TN, OK, CA, IL, MO, MN, Wash DC, including PR and the countries of Dominican Republic, Medico, Panama
- Lot
- Right Assembly: 43097, 44614, 43097R; Left Assembly: 43098, 44615, 43098R
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
Sell products like this?
Recalert watches your whole catalog for recalls like this one, automatically.