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

FDA device recall Z-1515-2026 · posted 2026-03-10 · Open, Classified

Recall details

Recalling firm

Waldemar Link GmbH & Co. KG (Mfg Site)

Reason for recall

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

Action taken

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 Complaint@link-ortho.com. 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.

Root cause

Under Investigation by firm

Status

Open, Classified

Product code

KRO

Quantity affected

1 unit (OUS only)

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, Sau

Date initiated

2026-01-12

Date posted

2026-03-10

Location

Norderstedt, Germany

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