FDAClass IIDecember 17, 2025

DEXLOCK Achilles Repair Implant Kits recall

DEXLOCK Achilles Repair Implant Kits, MAKT4520

Why was DEXLOCK Achilles Repair Implant Kits recalled?

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.

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot 19019 UDI-DI 10193489131703

Product
DEXLOCK Achilles Repair Implant Kits, MAKT4520
Recalling firm
Medline Industries, LP
Quantity
163 US
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.
Recall date
December 17, 2025
Classification
Class II
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls