Skip to content
Recall Observatory FDA recall evidence

Device product

DEXLOCK Achilles Repair Implant Kits, MAKT4520

Z-0911-2026

November 11, 2025

Class II

Product summary

Firm
Medline Industries, LP
Event
Event 98056
Status
Ongoing
Classification
Class II
Quantity
163 US
Official record key
device-enforcement:Z-0911-2026

Official wording

Reason: 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.

Code information: Lot 19019 UDI-DI 10193489131703

Distribution pattern: 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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.