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

The affected Endo-Model replacement set for a Rotating Hinge tibial plateau incorrectly contains a Pure Hinge plateau. The incorrect plateau could lead to a prolonged or modified surgery as the plateau cannot be inserted and an alternative product would be needed. If the incorrect plateau were to be implanted, this is associated with increased risk of wear, which could result in a reduced standing time of the implant.

Foreign manufacturer, Waldemar Link GmbH & Co KG, notified importer LinkBio Corp. on 7/6/2026 via email. LinkBio then notified the single US consignee by email/Docusign on 7/7/2026. Customer was instructed to return the affected product to LinkBio.

• FDA enforcement recordOfficial FDA database entry for Z-2934-2026
• FDA 510(k) clearance · K143179The 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.