FDA-Device2025-12-17Class II
DEXLOCK Achilles Repair Implant Kits, MAKT4520
Medline Industries, LP
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.
Sold states
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.
Affected count
163 US
Manufactured in
3 Lakes Dr, N/A, Northfield, IL, United States
Products
DEXLOCK Achilles Repair Implant Kits, MAKT4520
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0911-2026Don't want to check this manually?
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