Class II
Medical Device Recall: DEXLOCK Achilles Repair Implant Kits, MAKT4520
Medline Industries, LP · November 11, 2025
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.
States Affected
NATIONWIDE
Quantity Affected
163 US
Source: FDA (openFDA Device Enforcement)
Recall number: Z-0911-2026
Status: ongoing
SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.