Z-0911-2026 Class II Ongoing
FDA device recall Z-0911-2026 was initiated by Medline Industries, LP on November 11, 2025 and is designated Class II. 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. The recall status is ongoing. Affected quantity: 163 US.
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