The Recall Desk
Severity pendingFDA (Devices)·Z-0911-2026·Announced 2025-12-17

DEXLOCK Achilles Repair Implant Kits, MAKT4520

Pending LLM rewrite. Source: FDA_DEVICE Z-0911-2026.

Severity not yet assessed

We have not scored this recall against our rubric yet, so we are not showing a severity rating or our usual guidance. The agency’s own notice below is the authoritative source — read it first.

Plain-English summary

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 recalled product

Product
DEXLOCK Achilles Repair Implant Kits, MAKT4520
Manufacturer
Medline Industries, LP

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Lot 19019 UDI-DI 10193489131703

Distribution

Distributed nationwide across the United States.