🔍 RecallPedia

Hard Tissue Replacement (HTR) Implant, Rx only, for use in single procedure only. Custom made. HTR polymer implants are intended for bone replacement/augmentation for treatment of craniofacial voids/defects resulting from disease, injury, or surgical trauma.

Class I - Dangerous
🏥 Medical Devices Recalled: June 13, 2016 Biomet Microfixation Implants & Prosthetics

What Should You Do?

  1. Check if you have this product:
    Custom made, one per customer. Affected units were sealed between April 28, 2016 and June 7, 2016
  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 Microfixation, LLC
Reason for Recall:
Potential sterility deficiency.
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

Hard Tissue Replacement (HTR) Implant, Rx only, for use in single procedure only. Custom made. HTR polymer implants are intended for bone replacement/augmentation for treatment of craniofacial voids/defects resulting from disease, injury, or surgical trauma.

Product Codes/Lot Numbers:

Custom made, one per customer. Affected units were sealed between April 28, 2016 and June 7, 2016

Distribution:

Distributed in: US, AZ, CA, FL, MO, NH, PA, TX, VA

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-2751-2016

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