Endo Model Knee Fusion Nail SK recall
Endo Model Knee Fusion Nail SK, Knee Fusion Nail, Coupling Component, right, modular, L= 68 mm, Taper 10/12. Knee component of limb salvage…
Why was Endo Model Knee Fusion Nail SK recalled?
The device has been delivered with a preassembled locking screw that had been inserted from the wrong side into the male taper of the femoral component.
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: 15-0028/08; UDI-DI: 04026575175222; Lot Number: 2535004;
- Product
- Endo Model Knee Fusion Nail SK, Knee Fusion Nail, Coupling Component, right, modular, L= 68 mm, Taper 10/12. Knee component of limb salvage…
- Recalling firm
- Waldemar Link GmbH & Co. KG (Mfg Site)
- Quantity
- 18 units
- Distribution
- US distribution to states of: AL, GA, and TX.
- Recall date
- December 17, 2025
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)