Reported May 7, 2025 · Ongoing

L-Shaped Femoral Augment; Item Numbers: (1) 880-320/12 (Sz. 0 - cemented sm), (2) 880-320/22 (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?

12 of 12 products · 23 lot codes

Recalled lot codes, grouped by product number
Item NumbersLot codes and dates
880-320
  • 12Sz. 0 - cemented sm
  • (2)
880-320
  • 22Sz. 0 - cemented lg
  • (3)
880-321
  • 12Sz. 1-2 - cemented sm
  • (4)
880-321
  • 22Sz. 1-2 - cemented lg
  • (5)
880-323
  • 13Sz. 3-4 - cemented sm
  • (6)
880-323
  • 23Sz. 3-4 - cemented lg
  • (7)
880-325
  • 13Sz. 5-6 - cemented sm
  • (8)
880-325
  • 23Sz. 5-6 - cemented lg
  • (9)
880-327
  • 13Sz. 7-8 - cemented sm
  • (10)
880-327
  • 23Sz. 7-8 - cemented lg
  • (11)
Lot codes and dates

12 of 12 products · 24 lot codes

Recalled lot codes, grouped by product number
Item NumberUDI-DI
880-320
  • 1204026575258048
  • (2)
880-320
  • 2204026575258055
  • (3)
880-321
  • 1204026575258062
  • (4)
880-321
  • 2204026575258079
  • (5)
880-323
  • 1304026575258086
  • (6)
880-323
  • 2304026575258109
  • (7)
880-325
  • 1304026575258123
  • (8)
880-325
  • 2304026575258147
  • (9)
880-327
  • 1304026575258154
  • (10)
880-327
  • 2304026575258161
  • (11)
Amount recalled
441 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, 7:34 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.