Z-0239-2018 Class II Terminated
FDA device recall Z-0239-2018 was initiated by Amendia, Inc dba Spinal Elements on November 13, 2017 and is designated Class II. Reason for recall: Potential incorrect marking and color identification of Piranha screw. Some screws marked as 12 mm actually measure 14 mm. The recall status is terminated (terminated October 15, 2019). Affected quantity: 82 units.
Recall Details
- Product Type
- Devices
- Report Date
- December 20, 2017
- Initiation Date
- November 13, 2017
- Termination Date
- October 15, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 82 units
Product Description
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).
Reason for Recall
Potential incorrect marking and color identification of Piranha screw. Some screws marked as 12 mm actually measure 14 mm.
Distribution Pattern
US Distribution to the states of : AR, CA, GA, LA, MD, NV, NY, OH and TX.
Code Information
Part No. CSF-40-12, Lot No. 132635