Ad-Tech Medical Instrument Corporation recalls skull anchor bolts sold through May 30, 2019 due to potential MR environment use without approval. Affected units may pose safety risks if used in MRI settings.
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.
Ad-Tech Medical Instrument Corporation is recalling skull anchor bolts sold through May 30, 2019. These bolts may be used in MRI environments without proper approval, creating safety risks for medical procedures.
The bolts are approved for use in MRI environments but the recall states they are not approved for such use. This mismatch could lead to safety issues during medical procedures involving MRI scans.
Medical professionals using skull anchor bolts for brain surgery may be affected. Patients undergoing procedures with these bolts could face risks if exposed to MRI environments.
Check for skull anchor bolts with catalog numbers or lot numbers distributed through May 30, 2019. The product was sold by Ad-Tech Medical Instrument Corporation.
Identify if your skull anchor bolts were distributed through May 30, 2019 using catalog numbers or lot numbers.
The recall states that these bolts may be used in MRI environments without proper approval, which could create safety risks during medical procedures.
Check for skull anchor bolts with catalog numbers or lot numbers distributed through May 30, 2019.
The recall does not specify a remedy, so contact Ad-Tech Medical Instrument Corporation for further instructions.
We’ve drafted a message you can send Ad-Tech Medical Instrument Corporation to request your refund or repair — edit it as you like.
Subject: Recall Z-2408-2019 — Ad-Tech Medical Instrument Corporation Ad-Tech Medical Instrument Corporation Hello, I own a Ad-Tech Medical Instrument Corporation that is covered by recall Z-2408-2019 from Ad-Tech Medical Instrument Corporation. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
