🔍 RecallPedia

Integra External Fixation System Slotted Post - Small Catalogue #12224228; Integra External Fixation System Slotted Post Large Catalogue #12224229

Class I - Dangerous
🏥 Medical Devices Recalled: July 20, 2016 Integra LifeSciences Other Medical Devices

What Should You Do?

  1. Check if you have this product:
    Lot # QJ0139, QJ0148, QJ0140, QJ0149, QJ0287
  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:
Integra LifeSciences Corp.
Reason for Recall:
Through the investigation of reported complaints Integra verified that there have been instances where the Universal Wire Fixation Bolts the Slotted Post broke during use at the surgical site.
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

Integra External Fixation System Slotted Post - Small Catalogue #12224228; Integra External Fixation System Slotted Post Large Catalogue #12224229

Product Codes/Lot Numbers:

Lot # QJ0139, QJ0148, QJ0140, QJ0149, QJ0287

Distribution:

Distributed in: US, FL, VA, OK, CO, DC, IN

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-2387-2016

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Integra LifeSciences

Class I - Dangerous

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