🔍 RecallPedia

SmartTools Knee System Orthopedic Stereotaxic Instrument

Class I - Dangerous
🏥 Medical Devices Recalled: February 20, 2017 Orthosoft, Inc. Implants & Prosthetics Nationwide

What Should You Do?

  1. Check if you have this product:
    Lots: 130542A1 1405941 140146 140146-1 140147 140407A 140407A-1 140407B 140407-B-1 140860 140860-1 141035 150120 B150120 B150711
  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:
Orthosoft, Inc. dba Zimmer CAS
Reason for Recall:
There has been an increase in the number of complaints regarding bent or broken Drive Pins of the Validation Tool manufactured with drawing Revision M to P
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

SmartTools Knee System Orthopedic Stereotaxic Instrument

Product Codes/Lot Numbers:

Lots: 130542A1 1405941 140146 140146-1 140147 140407A 140407A-1 140407B 140407-B-1 140860 140860-1 141035 150120 B150120 B150711

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1868-2017

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