Reported Dec 17, 2025 · Ongoing
Endo Model Knee Fusion Nail SK, Knee Fusion Nail, Coupling Component, right, modular, L= 68 mm, Taper 10/12. Knee…
Waldemar Link GmbH & Co. KG (Mfg Site)
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Waldemar Link GmbH & Co. KG (Mfg Site) · Oststr. 4-10 · Norderstedt, N/A · N/A
Is this the product you have?
- Endo Model Knee Fusion Nail SK, Knee Fusion Nail, Coupling Component, right, modular, L= 68 mm, Taper 10/12. Knee component of limb salvage replacement devices.
- Lot codes and dates
- Item Number15-0028/08
- UDI-DI04026575175222
- Lot Number2535004
- Amount recalled
- 18 units
Where it was sold
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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