🔍 RecallPedia

Biomet Spine Lineum OCC Starter Flexible and Lineum Flexible Inner Shaft, Model Numbers 14-525050 and 14-525057, reusable devices distributed with bubble wrap inside a plastic pouch. The Lineum system is designed to facilitate reconstruction of the cervical and upper thoracic spine using bone screws, locking plugs, and various types of rods, hooks, and lateral connectors. One of the instruments used with this system is the Lineum Occipital Screw Starter with the inner shaft subassembly. The system comes with a fixed shaft Lineum Occipital Screw Driver, and a 90¿ driver in order to retain and drive the screw into the occipital bone.

Class I - Dangerous
🏥 Medical Devices Recalled: July 22, 2015 Biomet Spine Surgical Instruments Nationwide

What Should You Do?

  1. Check if you have this product:
    P/N 14-525050 Lot Number 001219 P/N 14-525057 Lot Number 001220
  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:
Biomet Spine, LLC
Reason for Recall:
Biomet has initiated a recall on Biomet Spine Lineum OCC Starter Flexible and its inner shaft instrumentsafter identifying that these instruments were distributed prior to completion of all design control activities.
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

Biomet Spine Lineum OCC Starter Flexible and Lineum Flexible Inner Shaft, Model Numbers 14-525050 and 14-525057, reusable devices distributed with bubble wrap inside a plastic pouch. The Lineum system is designed to facilitate reconstruction of the cervical and upper thoracic spine using bone screws, locking plugs, and various types of rods, hooks, and lateral connectors. One of the instruments used with this system is the Lineum Occipital Screw Starter with the inner shaft subassembly. The system comes with a fixed shaft Lineum Occipital Screw Driver, and a 90¿ driver in order to retain and drive the screw into the occipital bone.

Product Codes/Lot Numbers:

P/N 14-525050 Lot Number 001219 P/N 14-525057 Lot Number 001220

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-2759-2015

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Biomet Spine

Class I - Dangerous

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