Reported May 7, 2025 · Ongoing
Distal Femoral Augment; Item Numbers: (1) 880-300/11 (Sz. 0 - cemented sm), (2) 880-300/21 (Sz. 0 - cemented lg), (3)…
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
Is this the product you have?
20 of 20 products · 39 lot codes
| Item Numbers | Lot codes and dates |
|---|---|
880-300 |
|
880-300 |
|
880-301 |
|
880-301 |
|
880-303 |
|
880-303 |
|
880-303 |
|
880-303 |
|
880-305 |
|
880-305 |
|
- Lot codes and dates
20 of 20 products · 40 lot codes
Recalled lot codes, grouped by product number Item Number UDI-DI 880-3001104026575284931(2)
880-3002104026575257102(3)
880-3011104026575257133(4)
880-3012104026575257140(5)
880-3031104026575257171(6)
880-3031204026575257188(7)
880-3032104026575257195(8)
880-3032204026575257201(9)
880-3051104026575257256(10)
880-3051204026575257263(11)
- Amount recalled
- 1180 units
This recall covers 4 products
The agency filed one notice per product. You are reading one of them; the other 3 are below.
Where it was sold
Why it was recalled
The device was delivered with a preassembled Femoral Augment screw that was missing its thread.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
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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