# FDA recall Z-0239-2018

> **Amendia, Inc dba Spinal Elements** · Class II · device recall initiated 2017-11-13.

## 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.

## Distribution

US Distribution to the states of : AR, CA, GA, LA, MD, NV, NY, OH and  TX.

## Key facts

- **Recall number:** Z-0239-2018
- **Recalling firm:** Amendia, Inc dba Spinal Elements
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-11-13
- **Report date:** 2017-12-20
- **Termination date:** 2019-10-15

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Marietta, GA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0239-2018

## Citation

> AI Analytics. FDA recall Z-0239-2018. Retrieved 2026-05-29 from https://api.ai-analytics.org/recall/Z-0239-2018. Source: US FDA. Licensed CC0.

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