Medline Industries, LP: Medical Device Recall in 2025 - (Recall #: Z-0911-2026)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2025.

Data Source: FDA.

Product Description:

DEXLOCK Achilles Repair Implant Kits, MAKT4520

Product Classification:

Class II

Date Initiated: November 11, 2025

Date Posted: December 17, 2025

Recall Number: Z-0911-2026

Event ID: 98056

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.

Status: Ongoing

Product Quantity: 163 US

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.

Voluntary or Mandated:

Voluntary: Firm initiated