Endo-Model Replacement Plateau recall
Endo-Model Replacement Plateau; Item Number: 15-0027/16;
Why was Endo-Model Replacement Plateau recalled?
The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Item Number: 15-0027/16; UDI-DI: 04026575432134; Serial/Lot Number: 2550412, 2550413, 2549228;
- Product
- Endo-Model Replacement Plateau; Item Number: 15-0027/16;
- Recalling firm
- Waldemar Link GmbH & Co. KG (Mfg Site)
- Quantity
- 3 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.
- Recall date
- March 18, 2026
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)