United StatesDEXLOCK Achilles Repair Implant Kits (MAKT4520), lot 19019, UDI-DI 10193489131703 — 163 units distributed nationwide to hospitals/clinics in AL, AR, AZ, CO, DE, FL, GA, ID, IL, IN, KS, KY, LA, MA, MT, NC, NJ, OH, OK, PA, SC, TX, VA, WI — are affected. They were recalled after multiple complaints that a drill bit fused to the bushing/sleeve within the drill guide during use, which may require retrieving a replacement drill bit and drill guide and prolong the surgical procedure.
What's being recalled
DEXLOCK Achilles Repair Implant Kits, MAKT4520
Recalling firm: Medline Industries, LP, Northfield, IL, United States.
How to identify it
Lot 19019 UDI-DI 10193489131703
The hazard
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 to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
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.
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)