🔍 RecallPedia

PrimaConnex Tapered Implant TC, SD Internal Connection 3.5 x 10mm Catalog Number: l5613K. Implants in support for fixed bridgework.

Class I - Dangerous
🏥 Medical Devices Recalled: March 11, 2013 Keystone Dental Implants & Prosthetics

What Should You Do?

  1. Check if you have this product:
    Lot Number: 12857
  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:
Keystone Dental Inc
Reason for Recall:
Mislabeled: Cover screw that was in the package was a WD cover screw and not a SD cover screw as labeled
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

PrimaConnex Tapered Implant TC, SD Internal Connection 3.5 x 10mm Catalog Number: l5613K. Implants in support for fixed bridgework.

Product Codes/Lot Numbers:

Lot Number: 12857

Distribution:

Distributed in: DC, CA, FL, IN, MA, MN, NJ, NY, NH, PA, WI

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0973-2013

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