Ad-Tech Recalls Non-Sterile Anchor Bolts for Depth Electrodes
Ad-Tech Medical Instrument Corporation is recalling 201 non-sterile anchor bolts distributed without regulatory clearance or validated sterilization instructions.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II. The distribution of non-sterile medical devices without validated sterilization methods or regulatory clearance poses a significant risk of infection, meeting the criteria for a Severe rating.
Plain-English summary
Ad-Tech Medical Instrument Corporation is recalling 201 units of LSB Style Anchor Bolts. These devices are optional accessories used to stabilize Depth Electrodes in the skull to minimize concerns about cerebrospinal fluid leakage and infection. The recalled units include 13mm and 21mm anodized anchor bolt bodies with blue gaskets, and 13mm and 26mm non-anodized anchor bolt bodies with green or blue gaskets.
The recall was initiated because Ad-Tech personnel distributed non-sterile anchor bolt parts on three occasions between March 1, 2019, and May 31, 2019. Ad-Tech does not have regulatory clearance to distribute non-sterile anchor bolts, nor does it have a validated hospital sterilization method for these devices. Additionally, the product labeling does not include instructions for sterilizing the anchor bolts.
The devices were distributed worldwide, specifically in the state of Georgia, USA, and in Australia. Ad-Tech notified one independent representative and one international distributor who may have subsequently sterilized the non-sterile anchor bolts for clinical use. Users should contact Ad-Tech Medical Instrument Corporation for further instructions regarding the return or replacement of these devices.
The recalled product
- Product
- LSB Style Anchor Bolt. Labeled with the following parts: 13mm anodized anchor bolt body with anchor bolt cap containing a blue gasket and silicone cap, 21mm anodized anchor bolt body with anchor bolt cap containing a blue gasket and silicone cap, 13mm non-anodized anchor…
- Manufacturer
- Ad-Tech Medical Instrument Corporation
- Affected units
- 201
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 (3)
- All codes shipped between March 1
- 2019 and May 31
- 2019.
Distribution
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