🔍 RecallPedia

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).

Class I - Dangerous
🏥 Medical Devices Recalled: November 13, 2017 Amendia, Inc Surgical Instruments

What Should You Do?

  1. Check if you have this product:
    Part No. CSF-40-12, Lot No. 132635
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Amendia, Inc dba Spinal Elements
Reason for Recall:
Potential incorrect marking and color identification of Piranha screw. Some screws marked as 12 mm actually measure 14 mm.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
terminated

Product Information

Full 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).

Product Codes/Lot Numbers:

Part No. CSF-40-12, Lot No. 132635

Distribution:

Distributed in: US, AR, CA, GA, LA, MD, NV, NY, OH, TX

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0239-2018