FDAFDA · Food and drugs·Recall number Z-0239-2018
Piranha Screw 4.0 x 12mm, used in Piranha Surgical Plate System The Piranha Surgical Plate System is intended to provide stabilization of the cervical vertebrae for various indications as part of the Omni Spine Anterior Cervical Plate System. The Omni Spine Anterior Cervical Plate System is intended for anterior screw fixation to the cervical spine (C2-C7) as an adjustment to fusion in the treatment of degenerative disc disease (DDD), sponylolisthesis, spinal stenosis, tumors, trauma (i.e. fracture).
Published December 20, 2017 · Recall initiated: November 13, 2017
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 incorrect marking and color identification of Piranha screw. Some screws marked as 12 mm actually measure 14 mm.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Amendia, Inc dba Spinal Elements
- Distributor
- US Distribution to the states of : AR, CA, GA, LA, MD, NV, NY, OH and TX.
- Lot
- Part No. CSF-40-12, Lot No. 132635
- 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.