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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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.

The Hazard

The recall stems from multiple complaints of drill bits fusing to the bushing or sleeve within the drill guide. This malfunction poses a risk of prolonged surgical procedures, potentially affecting patient outcomes.

Reported Incidents

There have been no reported injuries or deaths associated with this recall. However, the high hazard level indicates a serious risk to patients undergoing procedures using these implants.

What to Do

Stop using the DEXLOCK Achilles Repair Implant Kits immediately. Patients and healthcare providers should follow the recall instructions from Medline Industries and contact their healthcare provider for further guidance.

Contact Information

For more information, contact Medline Industries, LP. Visit their website or call for detailed instructions regarding the recall.

Key Facts

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

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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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