🔍 RecallPedia

Navitrack¿ System - OS Knee Universal, Orthopedic Stereotaxic Instrument

Class I - Dangerous
🏥 Medical Devices Recalled: June 20, 2008 Orthosoft, Inc. Implants & Prosthetics

What Should You Do?

  1. Check if you have this product:
    Product Name: Orthosoft Universal TKR (software application) Product Number: ORTHOsoft-UniTkr-2 Affected Lot #: Software release version ORTHOsoft-UniTkr-2.2.0.82
  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:
ZIMMER CAS voluntarily conducted a retrospective recall of the Navitrack System - OS Knee Universal, due to software anomalies which were corrected with a new revision in version 2.2.1.3.
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

Navitrack¿ System - OS Knee Universal, Orthopedic Stereotaxic Instrument

Product Codes/Lot Numbers:

Product Name: Orthosoft Universal TKR (software application) Product Number: ORTHOsoft-UniTkr-2 Affected Lot #: Software release version ORTHOsoft-UniTkr-2.2.0.82

Distribution:

Distributed in: CA, FL, GA, IL, IN, KS, MD, MN, MS, NC, NJ, NY, OR, PA, RI, SD, TN, TX, WA, WI

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-2075-2017

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