HIGH

Medline Recalls DEXLOCK Achilles Repair Implant Kits Due to Surgical Risk

Medline Industries recalled 163 DEXLOCK Achilles Repair Implant Kits on November 11, 2025, due to a potential hazard. Users reported drill bits fusing to the drill guide, which may prolong surgical procedures. The recall affects kits distributed nationwide in multiple states.

Quick Facts at a Glance

Recall Date
November 11, 2025
Hazard Level
HIGH
Brand
Medline Industries, LP
Category
Health & Personal Care
Sold At
Multiple Retailers
Geographic Scope
1 states
At-Risk Groups
GENERAL

Hazard Information

There have been multiple complaints of drill bit fusing to the bushing/sleeve within the drill guide during use. Retrieving a replacement drill bit and drill guide may prolong the surgical procedure.

What You Should Do

Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Medline Industries, LP or your healthcare provider for instructions. Notification method: Letter

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About This Product

The DEXLOCK Achilles Repair Implant Kit is used in surgical procedures to repair Achilles tendon injuries. Healthcare providers purchase these kits for their critical role in ensuring successful surgeries.

Why This Is Dangerous

The defect occurs when the drill bit fuses to the bushing within the drill guide, which can hinder the surgical process and lead to complications.

Industry Context

This recall is not part of a broader industry pattern.

Real-World Impact

Patients may experience delays in surgical procedures, which can affect recovery times and overall health outcomes.

Practical Guidance

How to identify if yours is affected

  1. Locate the model number and lot number on the packaging or kit.
  2. Verify if the model number is MAKT4520 and lot number is Lot 19019 UDI-DI 10193489131703.
  3. Check any notification letters from Medline Industries for specific recall details.

Where to find product info

The model number and lot number are typically found on the product packaging or instruction manual.

What timeline to expect

Expect a refund or replacement processing time of approximately 4 to 6 weeks.

If the manufacturer is unresponsive

  • Document all attempts to contact Medline Industries.
  • Follow up with a phone call or email if no response is received within a week.
  • Consider contacting consumer protection agencies for assistance.

How to prevent similar issues

  • Always check for recent recalls on medical devices before use.
  • Ensure that your healthcare provider is aware of any recalls related to surgical tools.
  • Look for FDA approval and safety certifications when purchasing medical devices.

Documentation advice

Keep a record of your purchase receipt, any communication regarding the recall, and photographic evidence of the device.

Product Details

The recalled product is the DEXLOCK Achilles Repair Implant Kits, model MAKT4520, with lot number Lot 19019 UDI-DI 10193489131703. These kits were distributed across various states including Alabama, Texas, and Florida, and are classified as Class II medical devices.

Key Facts

  • Recall Date: November 11, 2025
  • Status: Active
  • Quantity Recalled: 163 kits
  • Distribution: Nationwide in 20 states
  • Classification: Class II

Safety Guide

Not sure what to do next? Our guide walks you through the process step by step.

Read: What to Do When You Find a Recalled Product

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Safety Assessment

Risk LevelHIGH
Severity Score
8/ 10
Affected Groups
GENERAL
Injury Types
OTHER

Product Classification

Product Details

Model Numbers
Lot 19019 UDI-DI 10193489131703
Affected States
ALL
Report Date
December 17, 2025
Recall Status
ACTIVE

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