🔍 RecallPedia

RBT, Internal Implant, Laser-Lok, 5.0 x 15mm, 5.7 Platform, REF LPBR5015, Rx only, Sterile R, BIOHORIZONS(R), Dental Implant

Class I - Dangerous
🏥 Medical Devices Recalled: October 30, 2015 BioHorizons Implant Systems Implants & Prosthetics

What Should You Do?

  1. Check if you have this product:
    Lot 1404442
  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:
BioHorizons Implant Systems Inc
Reason for Recall:
An incorrect label reading 10.5mm and not the specified 15mm was placed on the implant inner vial packaging.
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

RBT, Internal Implant, Laser-Lok, 5.0 x 15mm, 5.7 Platform, REF LPBR5015, Rx only, Sterile R, BIOHORIZONS(R), Dental Implant

Product Codes/Lot Numbers:

Lot 1404442

Distribution:

Distributed in: US, CA, CO, NY, OH, WA, AZ, MI, MD, GA, NC

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0391-2016

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