🔍 RecallPedia

KYPHON(R) Directional Bone Filler Device, Size: 3, REF F04C, Rx Only, STERILE R.

Class I - Dangerous
🏥 Medical Devices Recalled: May 17, 2017 Medtronic Sofamor Danek USA Other Medical Devices

What Should You Do?

  1. Check if you have this product:
    All Lots
  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:
Medtronic Sofamor Danek USA Inc
Reason for Recall:
The directional arrow at the proximal end of the instrument may not correctly align with the cutout opening on the distal end of the instrument. Using affected bone void filler may result in the injected cement being placed in a direction unintended by the surgeon.
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

KYPHON(R) Directional Bone Filler Device, Size: 3, REF F04C, Rx Only, STERILE R.

Product Codes/Lot Numbers:

All Lots

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-2247-2017

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