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

Recalled lot codes, grouped by product number
Item NumbersLot codes and dates
880-300
  • 11Sz. 0 - cemented sm
  • (2)
880-300
  • 21Sz. 0 - cemented lg
  • (3)
880-301
  • 11Sz. 1-2 - cemented sm
  • (4)
880-301
  • 21Sz. 1-2 - cemented lg
  • (5)
880-303
  • 11Sz. 3-4 - cemented sm
  • (6)
880-303
  • 12Sz. 3-4 - cemented md
  • (7)
880-303
  • 21Sz. 3-4 - cemented lg
  • (8)
880-303
  • 22Sz. 3-4 - cemented x-lg
  • (9)
880-305
  • 11Sz. 5-6 - cemented sm
  • (10)
880-305
  • 12Sz. 5-6 - cemented md
  • (11)
Lot codes and dates

20 of 20 products · 40 lot codes

Recalled lot codes, grouped by product number
Item NumberUDI-DI
880-300
  • 1104026575284931
  • (2)
880-300
  • 2104026575257102
  • (3)
880-301
  • 1104026575257133
  • (4)
880-301
  • 2104026575257140
  • (5)
880-303
  • 1104026575257171
  • (6)
880-303
  • 1204026575257188
  • (7)
880-303
  • 2104026575257195
  • (8)
880-303
  • 2204026575257201
  • (9)
880-305
  • 1104026575257256
  • (10)
880-305
  • 1204026575257263
  • (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.

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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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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 4:13 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.