The Recall Desk
Severity pendingFDA (Devices)·Z-0890-2026·Announced 2025-12-17

Endo Model Knee Fusion Nail SK, Knee Fusion Nail, Coupling Component, right, modular, L= 68 mm, Tap

Pending LLM rewrite. Source: FDA_DEVICE Z-0890-2026.

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

The device has been delivered with a preassembled locking screw that had been inserted from the wrong side into the male taper of the femoral component.

The recalled product

Product
Endo Model Knee Fusion Nail SK, Knee Fusion Nail, Coupling Component, right, modular, L= 68 mm, Taper 10/12. Knee component of limb salvage replacement devices.
Manufacturer
Waldemar Link GmbH & Co. KG (Mfg Site)

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 (3)

  • Item Number: 15-0028/08
  • UDI-DI: 04026575175222
  • Lot Number: 2535004

Distribution

Distributed in 3 states:

  • AL
  • GA
  • TX