FDA recall Z-0911-2026

Medline Industries, LP · Class II · device

Product

DEXLOCK Achilles Repair Implant Kits, MAKT4520

Reason for recall

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.

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.

Key facts

Status
Ongoing
Initiation date
2025-11-11
Report date
2025-12-17
Voluntary/Mandated
Voluntary: Firm initiated
Location
Northfield, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0911-2026