FDA Enforcement
Class II
Ongoing
DEXLOCK Achilles Repair Implant Kits, MAKT4520
Recall: Z-0911-2026
·
Reported December 17, 2025
Enforcement
- Recall Number
- Z-0911-2026
- Event ID
- 98056
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Medline Industries, LP
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- December 17, 2025
- Initiation Date
- November 11, 2025
- Classification Date
- December 11, 2025
- Address
- 3 Lakes Dr, N/A, Northfield, IL, 60093-2753, United States
Description
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.
Code Info
Lot 19019 UDI-DI 10193489131703
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.
Quantity
163 US