🔍 RecallPedia

Avitus¿ Bone Harvester w/ Filter Insert - 8mm intended to harvest cancellous bone and bone marrow Catalog Number: BH-110 The Avitus¿ Bone Harvester is intended to harvest cancellous bone and bone marrow

Class I - Dangerous
🏥 Medical Devices Recalled: February 18, 2019 Avitus Orthopaedics Other Medical Devices Nationwide

What Should You Do?

  1. Check if you have this product:
    Lot Number/Exp. Date Z2458218A 2018-05-01; Z2458253B 2018-05-01; Z2458379B 2018-10-01; Z2458448B 2019-01-01
  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:
Avitus Orthopaedics, Inc.
Reason for Recall:
Breach in the sterile barrier pouch may compromise sterility of the device.
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

Avitus¿ Bone Harvester w/ Filter Insert - 8mm intended to harvest cancellous bone and bone marrow Catalog Number: BH-110 The Avitus¿ Bone Harvester is intended to harvest cancellous bone and bone marrow

Product Codes/Lot Numbers:

Lot Number/Exp. Date Z2458218A 2018-05-01; Z2458253B 2018-05-01; Z2458379B 2018-10-01; Z2458448B 2019-01-01

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1046-2019

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