🔍 RecallPedia

Gyrus ACMI Round Cutting Burrs - to be used with the Diego Elite system

Class I - Dangerous
🏥 Medical Devices Recalled: August 3, 2017 Gyrus ACMI Other Medical Devices

What Should You Do?

  1. Check if you have this product:
    Catalog No. (UDI-DI): MBUR5060FRCV (00821925036529), MBUR6060FRCV (00821925036536), and MBUR7060FRCV (00821925036543) ALL LOTS MANUFACTURED BEFORE AUGUST 3, 2017
  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:
Gyrus ACMI, Inc.
Reason for Recall:
"Chattering" when cutting burrs are used in bone.
Classification:
Class I - Dangerous

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

Status:
ongoing

Product Information

Full Description:

Gyrus ACMI Round Cutting Burrs - to be used with the Diego Elite system

Product Codes/Lot Numbers:

Catalog No. (UDI-DI): MBUR5060FRCV (00821925036529), MBUR6060FRCV (00821925036536), and MBUR7060FRCV (00821925036543) ALL LOTS MANUFACTURED BEFORE AUGUST 3, 2017

Distribution:

Distributed in: NM, MI, TX, EU

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1337-2018

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