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

Recalling company

Waldemar Link GmbH & Co. KG (Mfg Site)

Product

Endo-Model Replacement Plateau; Item Number: 15-8521/15;

Reason

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

Classification

Class II – may cause temporary or medically reversible health consequences

Recall date

Jan 12, 2026

Reported

Mar 18, 2026

Distribution

Worldwide - US Nationwide distribution in the state of NJ and the countries of Belarus, Canada, Switzerland , Colombia, Germany, Spain, United Kingdom, Hungary, India, Italy, Netherlands, Romania, Saudi Arabia.

Status

Ongoing

Quantity

4 units (OUS only)

Lot / codes

Item Number: 15-8521/15; UDI-DI: 04026575383283; Serial/Lot Number: 250805/0020, 250805/0021, 250805/0023, 250805/0024;

Company location

Norderstedt, N/A

Recall type

Voluntary: Firm initiated

Recall number

Z-1520-2026

Agency

U.S. Food and Drug Administration (FDA)

View official FDA notice ↗ Search recall number Z-1520-2026 in the FDA Enforcement Report. Also see FDA recall press releases.