Skull Anchor Bolts

Class I - Dangerous

What Should You Do?

  1. Check if you have this product:
    All catalog numbers and lot numbers distributed through May 30, 2019
  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:
Ad-Tech Medical Instrument Corporation
Reason for Recall:
Supplemental information provided with devices may indicate that the subdural electrodes, depth electrodes, and anchor bolts are approved for use in the MR environment, for which they are not approved for such use.
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

Skull Anchor Bolts

Product Codes/Lot Numbers:

All catalog numbers and lot numbers distributed through May 30, 2019

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-2408-2019

Related Recalls

Ad-Tech is recalling these A-Style SD Depth Electrodes because a label discrepancy was identified on A style contact SD electrodes where the MR Conditional symbol was incorrectly placed instead of the MR Unsafe symbol. The A style contacts were not cleared for MR Conditional use. Our records indicate you have received one or more of the affected lots listed above.

Sep 19, 2024 Other Medical Devices Nationwide View Details →

Ad-Tech is recalling these A-Style SD Depth Electrodes because a label discrepancy was identified on A style contact SD electrodes where the MR Conditional symbol was incorrectly placed instead of the MR Unsafe symbol. The A style contacts were not cleared for MR Conditional use. Our records indicate you have received one or more of the affected lots listed above.

Sep 19, 2024 Other Medical Devices Nationwide View Details →

Ad-Tech is recalling these A-Style SD Depth Electrodes because a label discrepancy was identified on A style contact SD electrodes where the MR Conditional symbol was incorrectly placed instead of the MR Unsafe symbol. The A style contacts were not cleared for MR Conditional use. Our records indicate you have received one or more of the affected lots listed above.

Sep 19, 2024 Other Medical Devices Nationwide View Details →