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Open, Classified

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.

FDA Recall Z-0890-2026 · Posted 2025-12-09

Recalling FirmWaldemar Link GmbH & Co. KG (Mfg Site)
Recall StatusOpen, Classified
Product CodeKRO
Date Initiated2025-11-10
Product Quantity18 units

Reason for Recall

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.

Firm Action

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 [email protected] for any questions.

Root Cause

Process control

Distribution Pattern

US distribution to states of: AL, GA, and TX.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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