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Use caution Medical device recall · FDA · Published November 11, 2025

Medline DEXLOCK Achilles Repair Kits: Drill Bit Fusing Risk

Medline recalls DEXLOCK Achilles Repair Implant Kits (MAKT452:19019) due to drill bit fusing to the bushing during surgery, potentially prolonging procedures.

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

🇺🇸 FDA recall #Z-0911-2026Medical deviceMedline ›
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Contact the company

Recalling firmMedline Industries, LP3 Lakes Dr · Northfield, IL 60093-2753
✎ GovInfoNow plain-language explainer

Medline is recalling DEXLOCK Achilles Repair Implant Kits (MAKT4520) because drill bits can fuse to the bushing during surgery, which may lengthen the procedure. This is a safety concern for surgical teams using the kits. Read more at govinfonow.com/recall/50690-medline-dexlock-achilles-repair-kits-drill-bit-fusing-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/50690-medline-dexlock-achilles-repair-kits-drill-bit-fusing-risk · Updated August 18, 2026 · FDA enforcement record: FDA #Z-0911-2026

Cite this page

“Medline DEXLOCK Achilles Repair Kits: Drill Bit Fusing Risk.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/50690-medline-dexlock-achilles-repair-kits-drill-bit-fusing-risk. Based on FDA recall #Z-0911-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0911-2026%22&limit=1).

The FDA announced on Nov. 11, 2025, that Medline Industries, LP is recalling DEXLOCK Achilles Repair Implant Kits due to drill bit fusing issues. Owners should contact the company for a remedy.

How to tell if you have it

  • Brand: Medline
  • Product: DEXLOCK Achilles Repair Implant Kits
  • Model/Lot: MAKT4520, Lot 19019
  • UDI-DI: 10193489131703

The hazard

According to the FDA, there have been multiple complaints of drill bits fusing to the bushing or sleeve within the drill guide during use. This issue may prolong the surgical procedure when retrieving a replacement drill bit and guide.

Context

GovInfoNow's records show Medline Industries, LP has had 68 other recalls since July 31, 2025. Recent Medline recalls include homecare beds with potential fire hazards (Aug. 14, 2026), kits with fungal contamination risk (Aug. 11, 2026), and convenience kits with sharp-edged brushes (Aug. 10, 2026). Other recent recalls of similar products include Surgify Halo 5.4mm Drill Risk: Burr Breakage During Spinal Surgery (April 30, 2026), Howmedica DURACON XL Angled Tibial Implants Recall: Risk of Wear Debris and Revision Surgery (July 30, 2026), and Olympus HX-400U-30 Ligating Device Recall: Risk of Unintentional Loop Fixation (Oct. 30, 2025).

How to tell if you have this one

Check for the product name 'DEXLOCK Achilles Repair Implant Kits' and model number MAKT4520. Lot number 19019 is associated with this recall.

  • Brand
    Medline
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Check Product Details

    Identify the model number MAKT4520 and lot number 19019 on the kit packaging.

Where it went and when

Where it was distributed

Distributed nationwide; the notice names 24 states.

Alaska: nationwideAKMaine: nationwideMEVermont: nationwideVTNew Hampshire: nationwideNHWashington: nationwideWAIdaho: named in the noticeIDMontana: named in the noticeMTNorth Dakota: nationwideNDMinnesota: nationwideMNIllinois: named in the noticeILWisconsin: named in the noticeWIMichigan: nationwideMINew York: nationwideNYRhode Island: nationwideRIMassachusetts: named in the noticeMAOregon: nationwideORNevada: nationwideNVWyoming: nationwideWYSouth Dakota: nationwideSDIowa: nationwideIAIndiana: named in the noticeINOhio: named in the noticeOHPennsylvania: named in the noticePANew Jersey: named in the noticeNJConnecticut: nationwideCTCalifornia: nationwideCAUtah: nationwideUTColorado: named in the noticeCONebraska: nationwideNEMissouri: nationwideMOKentucky: named in the noticeKYWest Virginia: nationwideWVVirginia: named in the noticeVAMaryland: nationwideMDDelaware: named in the noticeDEArizona: named in the noticeAZNew Mexico: nationwideNMKansas: named in the noticeKSArkansas: named in the noticeARTennessee: nationwideTNNorth Carolina: named in the noticeNCSouth Carolina: named in the noticeSCDistrict of Columbia: nationwideDCOklahoma: named in the noticeOKLouisiana: named in the noticeLAMississippi: nationwideMSAlabama: named in the noticeALGeorgia: named in the noticeGAHawaii: nationwideHITexas: named in the noticeTXFlorida: named in the noticeFL

FDA distribution: “US Nationwide distribution in the states of AL, AR, AZ, CO, DE, FL, GA, ID, IL, IN, KS, KY, LA, MA, MT, NC, NJ, OH, OK, PA, SC, TX, VA, WI.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: Alabama, Arizona, Arkansas, Colorado, Delaware, Florida, Georgia, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Montana, New Jersey, North Carolina, Ohio, Oklahoma, Pennsylvania, South Carolina, Texas, Virginia, Wisconsin.

Recall timeline

FDA published this recall 36 days after the firm started it.

1. Firm started the recall: Nov 11, 202512. FDA classified it Class II: Dec 11, 202523. Published in FDA’s Enforcement Report: Dec 17, 202532025
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report

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-0911-2026 (November 11, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0911-2026 to see it in context.
  • Plain-language summary written by qwen3:4b on August 18, 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