Reported May 7, 2025 · Ongoing
Tibial Augment; Item Numbers: (1) 880-331/11 (Sz. 1-2 - cemented x-sm), (2) 880-331/12 (Sz. 1-2 - cemented sm), (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?
30 of 30 products · 59 lot codes
| Item Numbers | Lot codes and dates |
|---|---|
880-331 |
|
880-331 |
|
880-331 |
|
880-331 |
|
880-331 |
|
880-331 |
|
880-333 |
|
880-333 |
|
880-333 |
|
880-333 |
|
- Lot codes and dates
30 of 30 products · 59 lot codes
Recalled lot codes, grouped by product number Item Number UDI-DI 880-3311104026575258192(2)
880-3311204026575258208(3)
880-3311304026575258215(4)
880-3312104026575258222(5)
880-3312204026575258246(6)
880-3312304026575258253(7)
880-3331104026575258260(8)
880-3331204026575258277(9)
880-3331304026575258284(10)
880-3332104026575258291(11)
- Amount recalled
- 1771 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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