Waldemar Link GmbH & Co. KG (Mfg Site) recalls Endo Model Knee Fusion Nail SK

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.

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.

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 complaints@linkbio.com for any questions.

• FDA enforcement recordOfficial FDA database entry for Z-0890-2026
• 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.