Z-0911-2026 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- December 17, 2025
- Initiation Date
- November 11, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 163 US
Product Description
DEXLOCK Achilles Repair Implant Kits, MAKT4520
Reason for Recall
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.
Distribution Pattern
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.
Code Information
Lot 19019 UDI-DI 10193489131703