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Unrated Medical device recall · FDA · Published June 18, 2019

Ad-Tech LSB Anchor Bolts: Non-sterile parts risk infection during surgery

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.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-2204-2019Medical deviceAd-Tech ›
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Contact the company

Recalling firmAd-Tech Medical Instrument Corporation400 W Oakview Pkwy · Oak Creek, WI 53154-7213
✎ GovInfoNow plain-language explainer

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. Read more at govinfonow.com/recall/67650-ad-tech-lsb-anchor-bolts-non-sterile-parts-risk-infection.

Source Summary by GovInfoNow · govinfonow.com/recall/67650-ad-tech-lsb-anchor-bolts-non-sterile-parts-risk-infection · Updated August 17, 2026 · FDA enforcement record: FDA #Z-2204-2019

Cite this page

“Ad-Tech LSB Anchor Bolts: Non-sterile parts risk infection during surgery.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/67650-ad-tech-lsb-anchor-bolts-non-sterile-parts-risk-infection. Based on FDA recall #Z-2204-2019 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2204-2019%22&limit=1).

The FDA announced on June 18, 2019, that Ad-Tech Medical Instrument Corporation is recalling LSB Style Anchor Bolts due to non-sterile distribution. The agency stated the firm distributed non-sterile parts for potential clinical use without regulatory clearance or validated sterilization methods.

How to tell if you have it

  • Brand: Ad-Tech
  • Product: LSB Style Anchor Bolt
  • 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 bolt body with anchor bolt cap containing a green gasket and silicone cap
  • 26mm non-anodized anchor bolt body with anchor bolt cap containing a blue gasket and silicone cap
  • Codes shipped between March 1, 2019 and May 31, 2019

The hazard

Ad-Tech personnel distributed non-sterile anchor bolt parts to one independent representative and one international distributor between March 1, 2019, and May 31, 2019. The company lacks regulatory clearance to distribute non-sterile anchor bolts and does not have a validated hospital sterilization method for these devices. Ad-Tech labeling does not include instructions for sterilizing the anchor bolts.

Context

GovInfoNow's records show Ad-Tech Medical Instrument Corporation has 7 other recalls on record since December 20, 2017. Other recent recalls of similar products include Boston Scientific SC-4318 Clik X Anchor Recall (April 29, 2026), Aju Pharm Genesis Dual Thread Screw-In Anchor Recall (December 17, 2025), and LSL Healthcare Wound Closure Tray Model 7554: Non-sterile Alcohol Prep Pads Recall (March 9, 2026).

How to tell if you have this one

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.

  • Brand
    Ad-Tech
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Check Product Label

    Look for the product label indicating the specific bolt size and gasket color to confirm if it was part of the recall.

Where it went and when

Where it was distributed

Distributed nationwide, and outside the U.S.

Alaska: yesAKMaine: yesMEVermont: yesVTNew Hampshire: yesNHWashington: yesWAIdaho: yesIDMontana: yesMTNorth Dakota: yesNDMinnesota: yesMNIllinois: yesILWisconsin: yesWIMichigan: yesMINew York: yesNYRhode Island: yesRIMassachusetts: yesMAOregon: yesORNevada: yesNVWyoming: yesWYSouth Dakota: yesSDIowa: yesIAIndiana: yesINOhio: yesOHPennsylvania: yesPANew Jersey: yesNJConnecticut: yesCTCalifornia: yesCAUtah: yesUTColorado: yesCONebraska: yesNEMissouri: yesMOKentucky: yesKYWest Virginia: yesWVVirginia: yesVAMaryland: yesMDDelaware: yesDEArizona: yesAZNew Mexico: yesNMKansas: yesKSArkansas: yesARTennessee: yesTNNorth Carolina: yesNCSouth Carolina: yesSCDistrict of Columbia: yesDCOklahoma: yesOKLouisiana: yesLAMississippi: yesMSAlabama: yesALGeorgia: yesGAHawaii: yesHITexas: yesTXFlorida: yesFL

FDA distribution: “Worldwide distribution - US Nationwide distribution in the state of Georgia and country of Australia.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide, and outside the U.S.

Recall timeline

FDA terminated this recall 20 months after the firm started it.

1. Firm started the recall: Jun 18, 201912. FDA classified it Class II: Aug 6, 201923. Published in FDA’s Enforcement Report: Aug 14, 201934. FDA terminated the recall: Feb 16, 2021420192021
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report
  4. FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

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Where this comes from

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.

  • Official source: FDA Recall #Z-2204-2019 (June 18, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2204-2019 to see it in context.
  • Plain-language summary written by qwen3:4b on August 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA