Ad-Tech recalls LSB Style Anchor Bolts sold between March 2019 and May 2019 due to non-sterile parts distributed without proper sterilization instructions, posing infection risks in surgical procedures.
On June 12, 2019 Ad-Tech was made aware that on three different occasions between March 1, 2019 and May 31, 2019 Ad-Tech personnel have distributed non-sterile anchor bolt parts to one independent representative and one international distributor, who may have subsequently sterilized the non-sterile anchor bolts for clinical use. Ad-Tech does not have regulatory clearance to distribute non-sterile anchor bolts and does not have a validated hospital sterilization method for these devices. Further, Ad-Tech labeling does not include instructions for sterilizing anchor bolts.
Ad-Tech is recalling LSB Style Anchor Bolts made between March 1, 2019 and May 31, 2019 because they were distributed without being sterilized properly. These bolts are used in brain surgery to prevent infections, but the non-sterile parts could lead to serious infections if used in medical procedures.
Ad-Tech distributed non-sterile anchor bolts without regulatory approval or validated sterilization methods. The bolts were labeled for surgical use but lack instructions for sterilization, increasing infection risks during procedures.
Patients undergoing brain surgery who might have received these non-sterile anchor bolts. Medical professionals using the bolts without proper sterilization procedures are at risk.
Check for LSB Style Anchor Bolts labeled with 13mm or 21mm anodized bodies with blue gaskets, or 13mm/26mm non-anodized bodies with green/blue gaskets. These were sold between March 1, 2019 and May 31, 2019.
Look for the product label indicating the specific bolt size and gasket color to confirm if it was part of the recall.
Ad-Tech distributed non-sterile anchor bolts without regulatory approval and without validated sterilization methods, which could lead to infection risks.
No, these bolts were distributed without proper sterilization, posing infection risks during surgical procedures.
Check for LSB Style Anchor Bolts labeled with 13mm or 21mm anodized bodies with blue gaskets, or 13mm/26mm non-anodized bodies with green/blue gaskets, sold between March 1, 2019 and May 31, 2019.
We’ve drafted a message you can send Ad-Tech to request your refund or repair — edit it as you like.
Subject: Recall Z-2204-2019 — Ad-Tech Ad-Tech Hello, I own a Ad-Tech that is covered by recall Z-2204-2019 from Ad-Tech. 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.
