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Medline Industries, LP: DEXLOCK Achilles Repair Implant Kits, MAKT4520

Medical DevicesSource: FDA (device) · Date: 2025-12-17

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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.

Company / brand
Medline Industries, LP
Product
DEXLOCK Achilles Repair Implant Kits, MAKT4520
Reason / 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.
Classification
Class II
Status
Ongoing
Distribution / sold at
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 initiated
2025-11-11
Code info
Lot 19019 UDI-DI 10193489131703
Product quantity
163 US
Voluntary mandated
Voluntary: Firm initiated
City
Northfield
State
IL
Country
United States
Event id
98056
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