FDAHealthNovember 11, 2025

Medline Industries, LP — DEXLOCK Achilles Repair Implant Kits, MAKT4520

⚠️ 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.

Is this relevant to me?

Geography: Nationwide
Source agency: FDA
Category: Health
Published: November 11, 2025

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.

What's affected?

Product: DEXLOCK Achilles Repair Implant Kits, MAKT4520
Brand: Medline Industries, LP
Lot code: 19019

Additional details

Lot 19019 UDI-DI 10193489131703

What should I do?

Recommended action

Class II recall. Voluntary: Firm initiated Quantity affected: 163 US.

View original FDA notice →

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