Buy me a coffee
Home › FDA recalls › DEXLOCK Achilles Repair Implant Kits
CLASS II · ModerateFDA

Medline Industries, LP recalls DEXLOCK Achilles Repair Implant Kits

📅 Nov 11, 2025 · 📍 Nationwide
Recalling company
Medline Industries, LP
Product
DEXLOCK Achilles Repair Implant Kits, MAKT4520
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.
Classification
Class II – may cause temporary or medically reversible health consequences
Recall date
Nov 11, 2025
Reported
Dec 17, 2025
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.
Status
Ongoing
Quantity
163 US
Lot / codes
Lot 19019 UDI-DI 10193489131703
Company location
Northfield, IL
Recall type
Voluntary: Firm initiated
Recall number
Z-0911-2026
Agency
U.S. Food and Drug Administration (FDA)

View official FDA notice ↗ Search recall number Z-0911-2026 in the FDA Enforcement Report. Also see FDA recall press releases.

If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.