🔍 RecallPedia

Truliant Splined Stem Extension, 18mm x 120mm - Product Usage: The devices are used in a cemented total knee prosthesis system, which provides femoral components, tibial inserts, stems, augments, and surgical instrumentation for use in primary and revision total knee arthroplasty.

Class I - Dangerous
🏥 Medical Devices Recalled: January 27, 2020 Exactech Implants & Prosthetics Nationwide

What Should You Do?

  1. Check if you have this product:
    Catalog no: 02-012-64-1812 Serial number: 6366405, 6367075, 6367076
  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:
Exactech, Inc.
Reason for Recall:
These Truliant Splined Stem Extension, 18mm x 120mm were found to have a labeling error. The upper right corner of the label incorrectly identifies the implant size as 17mm x 80mm when the implant size is 18mm x 120mm.
Classification:
Class I - Dangerous

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

Status:
ongoing

Product Information

Full Description:

Truliant Splined Stem Extension, 18mm x 120mm - Product Usage: The devices are used in a cemented total knee prosthesis system, which provides femoral components, tibial inserts, stems, augments, and surgical instrumentation for use in primary and revision total knee arthroplasty.

Product Codes/Lot Numbers:

Catalog no: 02-012-64-1812 Serial number: 6366405, 6367075, 6367076

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1364-2020

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