Recall Z-0239-2018 ยท KWQ Appliance, Fixation, Spinal Intervertebral Body
Amendia, Inc dba Spinal Elements
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 treatm
| Date | Nov 13, 2017 |
| Status | Terminated |
| Reason | Potential incorrect marking and color identification of Piranha screw. Some screws marked as 12 mm actually measure 14 mm. |
| Root cause | Labeling mix-ups |
| 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. |
| Quantity | 82 units |
| Distribution | US Distribution to the states of : AR, CA, GA, LA, MD, NV, NY, OH and TX. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K092531 | SPINE360 ANTERIOR CERVICAL PLATE SYSTEM Spine360, Feb 4, 2010 |