Device product
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).
Z-0239-2018
Product summary
- Event
- Event 78592
- Status
- Terminated
- Classification
- Class II
- Quantity
- 82 units
- Official record key
device-enforcement:Z-0239-2018
Official wording
Reason: Potential incorrect marking and color identification of Piranha screw. Some screws marked as 12 mm actually measure 14 mm.
Code information: Part No. CSF-40-12, Lot No. 132635
Distribution pattern: US Distribution to the states of : AR, CA, GA, LA, MD, NV, NY, OH and TX.
Derived failure modes
-
Unknown
Potential incorrect marking and color identification of Piranha screw. Some screws marked as 12 mm actually measure 14 mm.