Device product
DEXLOCK Achilles Repair Implant Kits, MAKT4520
Z-0911-2026
Product summary
- Event
- Event 98056
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 163 US
- Official record key
device-enforcement:Z-0911-2026
Official wording
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 information: Lot 19019 UDI-DI 10193489131703
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.
Derived failure modes
-
Unknown
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.