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).
FDA Recall Z-0239-2018 · Posted None
Recalling FirmAmendia, Inc dba Spinal Elements
Recall StatusTerminated
Product CodeKWQ
Date Initiated2017-11-13
Date Terminated2019-10-15
Product Quantity82 units
Reason for Recall
Potential incorrect marking and color identification of Piranha screw. Some screws marked as 12 mm actually measure 14 mm.
Firm Action
Spinal Elements sent an Urgent Medical Device Recall letter dated November 13, 2017. Instructions included to examine inventory and quarantine affected products, complete and return the response form, arrange for return of any affected product, and to notify customers if further distributed. For further questions, please call (770) 575-5274.
Root Cause
Labeling mix-ups
Distribution Pattern
US Distribution to the states of : AR, CA, GA, LA, MD, NV, NY, OH and TX.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.