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Fusion Nail recallZ-0890-2026 · Waldemar Link GmbH & Co. KG (Mfg Site) · initiated Nov 10, 2025

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Waldemar Link GmbH & Co. KG (Mfg Site) or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was 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.

FDA root cause category: Process control

What the company is doing

On November 10, 2025, URGENT: MEDICAL DEVICE RECALL letters were emailed to distributors. Actions to be taken: Please respond using the attached Distributor Reply form to indicate your understanding of this Device Recall and of the need to return the affected product. Please return the product as soon as possible to the following address: LinkBio Corporation 69 King St Dover, NJ 07801 Please contact LinkBio at 973-625-1333 or [email protected] for any questions.

Recall details

Recall number
Z-0890-2026
Status
Open, Classified
Initiated by the company
Nov 10, 2025
Posted by the FDA
Dec 9, 2025
Recalling firm
Waldemar Link GmbH & Co. KG (Mfg Site)
Quantity
18 units
Product code
KRO
FDA submissions
K151008
Distribution
US distribution to states of: AL, GA, and TX.

Product description

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.

Code information (models, lots, serial numbers)

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

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other devices under the same FDA submission

36 devices cleared under K151008 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Sources and updates

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