FDA Device recall 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 t…
- FDA Device
- Class II
- terminated
- Published 2017-12-20
On 2017-12-20 the FDA classified a Class II recall of Piranha Screw 4.0 x 12mm, used in Piranha Surgical Plate System The Piranha Surgical Plate System is intended to provide stabilization of t… by Amendia, citing potential incorrect marking and color identification of Piranha screw. Some screws marked as 12 mm actually measure 14 mm.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0239-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-11-13 |
| Published | 2017-12-20 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Amendia |
| Distribution | AR, CA, GA, LA, MD, NV, NY, OH, TX |
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).
Reason
Potential incorrect marking and color identification of Piranha screw. Some screws marked as 12 mm actually measure 14 mm.
Identifiers
| code_info | Part No. CSF-40-12, Lot No. 132635 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Other recalls by Amendia
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FDA Device · Class II · 2018-01-17 · Amendia - Ceres Self-Drilling Variable Screw 4.0 x 12mm The Ceres screws are self-drilling variable screws that are intended to be used with the Cere…
FDA Device · Class II · 2018-01-10 · Amendia - 01.4mm x 457mm (18in) K-Wire, Threaded Blunt, Ref 9080B-18T, Qty: 1 per pack, Material: SS 316L, Full Temper, per ASTM F138, Amendia, 1755…
FDA Device · Class II · 2017-05-03 · Amendia - Ceres-C Standalone Cervical Interbody The product is a stand-alone anterior cervical interbody fusion device indicated for use in skeletall…
FDA Device · Class II · 2017-01-18 · Amendia - Dual Stylet Needle, Part Number 812-11R-15 The guide wire is passed through the cannulated handle of the Dual Stylet Needles and pressed in…
FDA Device · Class II · 2016-12-28 · Amendia
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0239-2018%22
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