Skip to content

Endo-Model Modular Knee Prosthesis System recallZ-1515-2026 · Waldemar Link GmbH & Co. KG (Mfg Site) · initiated Jan 12, 2026

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 potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture.

FDA root cause category: Under Investigation by firm

What the company is doing

On or about January 12, 2026 URGENT FIELD SAFETY NOTICE Product Recall letters were sent to customers. Actions to be taken: Review inventory to identify and quarantine any affected product. Return any unused product to the manufacturer. Follow patient management recommendations, if implanted. A custom-made replacement set can be requested. If an affected product is noticed during implantation, another plateau screw from a replacement set or different LINK knee prosthesis package can be used. If this situation occurs, a complaint form must be completed and sent to [email protected]. The replacement of the affected products will begin as soon as replacement products are available. Replacement will not incur any costs to you. Should you have any questions on acquiring replacements for forthcoming surgeries, please contact your local sales representative or customer service for Link products.

Recall details

Recall number
Z-1515-2026
Status
Open, Classified
Initiated by the company
Jan 12, 2026
Posted by the FDA
Mar 10, 2026
Recalling firm
Waldemar Link GmbH & Co. KG (Mfg Site)
Quantity
1 unit (OUS only)
Product code
KRO
FDA submissions
K151008
Distribution
Worldwide - US Nationwide distribution in the state of NJ and the countries of Belarus, Canada, Switzerland , Colombia, Germany, Spain, United Kingdom, Hungary, India, Italy, Netherlands, Romania, Saudi Arabia.

Product description

Endo-Model Replacement Plateau; Item Number: 15-2835/12;

Code information (models, lots, serial numbers)

Item Number: 15-2835/12; UDI-DI: 04026575316564; Serial/Lot Number: 241210/1809;

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

37 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.

Other products in the same recall event

The FDA groups related products into one recall event (event 98342).

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page