The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-2408-2019·Announced 2019-09-04

Ad-Tech Skull Anchor Bolts Recalled for Incorrect MRI Approval Labeling

Ad-Tech Medical Instrument Corporation is recalling Skull Anchor Bolts because supplemental information incorrectly indicated they were approved for use in the MR environment.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: This is a Class II recall involving a labeling error regarding MRI approval. The hazard is theoretical as no injuries or illnesses are reported, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

Ad-Tech Medical Instrument Corporation is recalling Skull Anchor Bolts. The recall involves 22,810 devices distributed nationwide and worldwide. The devices were distributed through May 30, 2019.

The recall was initiated because supplemental information provided with the devices may indicate that the subdural electrodes, depth electrodes, and anchor bolts are approved for use in the MR environment. The devices are not approved for such use.

This recall is classified as Class II by the FDA. Consumers and healthcare providers should verify the approval status of these devices before use in magnetic resonance imaging environments.

The recalled product

Product
Skull Anchor Bolts
Manufacturer
Ad-Tech Medical Instrument Corporation
Category
Medical Device — Neurological Monitoring
Hazard
Affected units
22,810

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

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

Distribution

Distributed nationwide across the United States.

The notice also names 52 states specifically:

Part of a larger recall action

This product is one of 3 recalled by Ad-Tech Medical Instrument Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 3 products in this recall →

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