Piranha Screw 4 — Class II medical device recall Z-0239-2018
Terminated recall by Amendia, Inc dba Spinal Elements, reported 2017-12-20, distributed in AR, CA, GA, LA, MD, NV, NY, OH…. Potential incorrect marking and color identification of Piranha screw. Some screws marked as 12 mm actually me
| Recall number | Z-0239-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Amendia, Inc dba Spinal Elements, Marietta, GA, United States |
| Recall initiated | 2017-11-13 |
| Classified | 2017-12-13 |
| Reported by FDA | 2017-12-20 |
| Terminated | 2019-10-15 |
| Distributed | AR, CA, GA, LA, MD, NV, NY, OH, TX |
| Quantity | 82 units |
| Lot numbers | 132635 |
| Model numbers | CSF-40-12 |
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 for recall
Potential incorrect marking and color identification of Piranha screw. Some screws marked as 12 mm actually measure 14 mm.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0239-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.