WhichRecall
Class IIReported 2025-12-17

DEXLOCK Achilles Repair Implant Kits, MAKT4520

Recalled by Medline Industries, LP

Reason for Recall

There have been multiple complaints of drill bit fusing to the bushing/sleeve within the drill guide during use

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Retrieving a replacement drill bit and drill guide may prolong the surgical procedure.

Recall Number
Z-0911-2026
Classification
Class II
Status
Ongoing
Category
device
Initiated
2025-11-11
Reported
2025-12-17
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.
Code Info
Lot 19019 UDI-DI 10193489131703
Source: openFDA enforcement report. WhichRecall is not affiliated with the FDA. See our disclaimer.
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