🔍 RecallPedia

Tritium Sternal Plate System, Screw, 02.7mm X 12mm, 12 Pack, Sterile. The Pioneer Surgical Cable Plate System is used in the stabilization and fixation of fractures of the anterior chest wall including Sternal fixation following Sternotomy and Sternal reconstructive surgical procedures. The screws are packaged as a 12 pack using a double tray packaging configuration.

Class I - Dangerous
🏥 Medical Devices Recalled: June 11, 2014 PIONEER SURGICAL TECHNOLOGY Surgical Instruments Nationwide

What Should You Do?

  1. Check if you have this product:
    Model: 86-27-12-S12 UDI Number: 00846468061463 LOT: 168952 Expiration:12/23/2018
  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:
PIONEER SURGICAL TECHNOLOGY, INC.
Reason for Recall:
Lack of Sterility Assurance
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

Tritium Sternal Plate System, Screw, 02.7mm X 12mm, 12 Pack, Sterile. The Pioneer Surgical Cable Plate System is used in the stabilization and fixation of fractures of the anterior chest wall including Sternal fixation following Sternotomy and Sternal reconstructive surgical procedures. The screws are packaged as a 12 pack using a double tray packaging configuration.

Product Codes/Lot Numbers:

Model: 86-27-12-S12 UDI Number: 00846468061463 LOT: 168952 Expiration:12/23/2018

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-2076-2014

Related Recalls

Streamline MIS Spinal Fixation System Fixed Rod Holder NON STERILE, Rx only The Streamline MIS Spinal Fixation System is intended for posterior, noncervical pedicle fixation, T1-S2. Pedicle screw fixation is limited to skeletally mature patients and is intended to be used as an adjunct to fusion. The device is indicated for all the following indications: degenerative disc disease (ODD) (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e. fracture or dislocation); spinal stenosis; deformities or curvatures (i.e. scoliosis, kyphosis, and /or lordosis); tumor; pseudoarthrosis; and failed previous fusion. The Streamline MIS instrumentation, when used with the Streamline MIS Spinal Fixation System, is indicated to provide the surgeon with a minimally invasive approach for posterior spinal surgery.

PIONEER SURGICAL TECHNOLOGY

Class I - Dangerous

The affected fixed rod holders did not allow the instrument to lock down on the spinal rod.

Jun 14, 2013 Surgical Instruments Nationwide View Details →