Waldemar Link GmbH & Co. KG (Mfg Site) recalls Endo-Model Replacement Plateau

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

Endo-Model Replacement Plateau; Item Number: 15-0027/12;

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.

• FDA enforcement recordOfficial FDA database entry for Z-1522-2026
• FDA 510(k) clearance · K151008The device's official FDA premarket clearance record
• FDA device classification · KROOfficial FDA classification for this device type
• CFR regulation · 21 CFR 888.3510The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Waldemar Link GmbH & Co. KG (Mfg Site)Search for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.