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

Recall Insight

This FDA Devices action (record #Z-1520-2026) was formally reported on March 18, 2026, with the manufacturer initiating the action on January 12, 2026. It is classified under Moderate severity (Class II), with a current status of Ongoing. Waldemar Link GmbH & Co. KG (Mfg Site) is listed as the recalling firm, operating out of Norderstedt, N/A. Federal records indicate 4 units (OUS only) units are affected.

The documented reason for this recall is: The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture. Distribution data in the federal record shows the product reached: 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.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

To put this record in context, PlainRecalls indexes 83,949 recalls across the FDA, CPSC, NHTSA and USDA FSIS going back to 1995. Within the same product category, the database holds 6 closely related recalls, of which 6 were also issued by FDA Devices and 1 involve the same firm, Waldemar Link GmbH & Co. KG (Mfg Site). That clustering is a signal — repeated actions in a narrow category often indicate a systemic quality-control issue, a supplier-wide contamination, or a design defect that has propagated across product lines. Because this recall is recent, remedy windows and replacement inventory are most likely still actively available from the firm or retailer. Always cross-check the recall number against the official agency page before relying on any summary.