Class II U.S. Food and Drug Administration

Waldemar Link GmbH & Co. KG Endo Model Knee Fusion Nail SK, Knee Fusion Nail recall: The device has been delivered with a preassembled locking screw that had

Recall published 10 months ago

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 hazard: Device safety concern

This is a device enforcement record. Check whether the remedy is a correction, a software update or a removal before changing anything.

What the notice says: 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.

Why it matters: The FDA recorded an enforcement action against this device. Most device recalls are corrections rather than removals, so the device often stays in use while the manufacturer issues a fix.

Recall details

Recall number
Z-0890-2026
Published
December 17, 2025
Risk level
Class II
Status
Ongoing
Issued by
U.S. Food and Drug Administration
Brand
Waldemar Link GmbH & Co. KG
Product type
Medical devices
Units affected
18 units
Distribution
Alabama, Georgia, Texas
Made in
Germany
Lot / code info
Item Number: 15-0028/08; UDI-DI: 04026575175222; Lot Number: 2535004;
UPC codes
04026575175222

Products covered by this recall

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.

Check your product

The notice names 5 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

UPC / barcode

Read the twelve digits under the barcode on the package.

  • 04026575175222

Lot or batch code

Usually ink-stamped near the seam, the cap or the bottom of the pack.

  • 2535004

Model or item number

On the rating label, the box or the instruction sheet.

  • Knee Fusion Nail SK
  • 15-0028
  • 08

Codes are lifted verbatim from the FDA — Device enforcement notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Device

Waldemar Link GmbH & Co. KG — This is a device enforcement record. Check whether the remedy is a correction, a software update or a removal before changing anything.

  1. Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.
  2. Ask the supplier or clinic that provided it what the remedy is in your case.
  3. If you are a facility, quarantine affected stock and log the correction.
  4. Report device problems to the FDA through MedWatch.

Replacements, repairs and reimbursement

Device remedies run through the supply chain, so the route depends on who sold you the unit.

  • Contact the distributor or clinic named on your paperwork and quote the recall number on this page. They will tell you whether the remedy is a repair, a replacement or an instruction update.
  • If the device was billed to insurance or Medicare, the replacement is usually billed the same way; you should not face a second deductible for a recall.
  • Keep every piece of correspondence. If a recalled device caused harm, that paper trail is what a claim rests on.
  • Consumer-purchased devices such as monitors and test kits are normally replaced free, with return shipping paid.

Company contact: Waldemar Link GmbH & Co. KG (Mfg Site) — Oststr. 4-10, Norderstedt

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Device enforcement record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was Waldemar Link GmbH & Co. KG medical devices recalled?

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 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.

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: UPC 04026575175222; lot code 2535004; model number Knee Fusion Nail SK, 15-0028, 08. If the code on your package is not on that list, your unit is outside the recall.

What should I do with it right now?

Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.

Can I get my money back?

Contact the distributor or clinic named on your paperwork and quote the recall number on this page. They will tell you whether the remedy is a repair, a replacement or an instruction update.

Which states were affected?

The notice lists Alabama, Georgia, Texas.

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