Waldemar Link GmbH Class II Device Recall

FDA: Device Recalls Class II

Filed March 18th, 2026

Detected March 23rd, 2026

Summary

The FDA is reporting an ongoing Class II device recall initiated voluntarily by Waldemar Link GmbH & Co. KG for their Endo-Model Replacement Plateau. The recall affects 2 units distributed worldwide, including in the US, due to a potential for implant component detachment.

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What changed

The FDA has reported an ongoing Class II device recall for Waldemar Link GmbH & Co. KG's Endo-Model Replacement Plateau (Item Number: 15-0027/11). The recall, initiated voluntarily by the firm, affects 2 units distributed internationally, including nationwide distribution in the US (NJ) and several other countries. The reason for the recall is the potential for an implant with a plateau screw to experience bushing detachment from the screw shaft due to a longitudinal fracture.

This action requires immediate attention from any entities that may have received or distributed these specific units. Compliance officers should verify inventory and distribution records to ensure affected units are accounted for and removed from circulation. While the recall is voluntary, the classification as Class II indicates a potential for adverse health consequences. The FDA's report date is March 18, 2026, with the recall initiation date being January 12, 2026.

What to do next

Review distribution records for affected Endo-Model Replacement Plateau units (Item Number: 15-0027/11; Serial/Lot Number: 2549126, 2549127).
Ensure removal of any affected units from inventory and distribution channels.
Confirm compliance with voluntary recall procedures as initiated by Waldemar Link GmbH & Co. KG.

Source document (simplified)

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