FDAFDA · Food and drugs·Recall number Z-1869-2013
Caddy - PedFuse, Screw Caddy, 8MM and 9MM, Part Number: 11-80009 Rev. B The caddy holds, in an organized fashion within the case, 8mm and 9mm pedicle screws used during implantation of pedicle screw system devices intended to provide immobilization and stabilization of spinal segments of skeletally mature patients
Published August 7, 2013 · Recall initiated: October 5, 2012
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
Two sections that are designated for the 8mm and 9mm screws were switched; the holes that hold the 8mm screws are designed for 9mm screws, and the holes that hold the 9mm screws are designated for 8mm screws.
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- SpineFrontier, Inc.
- Distributor
- US distribution in states of: CO, DC, MA and TX.
- Lot
- 31176, 018652, 018645R, 42011
- 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.