FDAFDA · Food and drugs·Recall number Z-1521-2026
Endo-Model Replacement Plateau; Item Number: 15-0027/11;
Published March 18, 2026 · Recall initiated: January 12, 2026
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Waldemar Link GmbH & Co. KG (Mfg Site)
- Distributor
- 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.
- Lot
- Item Number: 15-0027/11; UDI-DI: 04026575431953; Serial/Lot Number: 2549126, 2549127;
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- Germany
Sell products like this?
Recalert watches your whole catalog for recalls like this one, automatically.