🔍 RecallPedia

NavitrackER Kit A: Knee, Model Number 20-8000-000-07,

Class I - Dangerous
🏥 Medical Devices Recalled: January 7, 2022 Orthosoft, Inc. Implants & Prosthetics Nationwide

What Should You Do?

  1. Check if you have this product:
    Lot number 110221A1 UDI Number (01)00889024304222 (17)231103(10)110221A1
  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:
The product was released for distribution without passing sterilization results, which could potentially lead to insufficient sterility of the product. The highest severity risk is infection leading to surgical intervention.
Classification:
Class I - Dangerous

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

Status:
ongoing

Product Information

Full Description:

NavitrackER Kit A: Knee, Model Number 20-8000-000-07,

Product Codes/Lot Numbers:

Lot number 110221A1 UDI Number (01)00889024304222 (17)231103(10)110221A1

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0721-2022

Related Recalls

Sesamoid Plasty, Stereotaxic Instrument The Sesamoid Plasty workstation is used to run the tracking software as part of the software based navigation systems. The affected Sesamoid Plasty components are the central structural column and its base that hold up the computer and the tracking camera on the Sesamoid Plasty workstation. They are also designed to be disassembled such that the column can be folded onto itself for ease of transport after use. This is a retrospective recall report for a removal initiated on 17 June 2008

Orthosoft, Inc.

Class I - Dangerous

Zimmer CAS voluntarily conducted a retrospective recall of the Sesamoid Plasty due to the risk of the top of the workstation to potentially fall over during disassembly.

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