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

Recall date

November 11, 2025

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0911-2026

FDA classification

Class II

Brand / firm

Medline Industries, LP

Sold / distributed

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.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

DEXLOCK Achilles Repair Implant Kits, MAKT4520