HIGH

Endo-Model Replacement Plateau; Item Number: 15-8521/09;

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

Quick Facts at a Glance

Recall Date
January 12, 2026
Hazard Level
HIGH
Brand
Waldemar Link GmbH & Co. KG
Geographic Scope
1 states

Hazard Information

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

What You Should Do

Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Waldemar Link GmbH & Co. KG (Mfg Site) or your healthcare provider for instructions. Notification method: Letter

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Full Description

Endo-Model Replacement Plateau; Item Number: 15-8521/09;. 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. Quantity: 8 units (OUS only). 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.

View Original Recall on FDA - Medical Devices

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Product Classification

Product Details

Model Numbers
Item Number: 15-8521/09
UDI-DI: 04026575383238
Serial/Lot Number: 250728/0038
250728/0039
250728/0040
+5 more
Affected States
ALL
Report Date
March 18, 2026
Recall Status
ACTIVE

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