The Recall Desk
HighFDA (Devices)·Z-1702-2025·Announced 2025-05-07

Tibial Augment Femoral Screw Recalled for Missing Thread

Waldemar Link is recalling Tibial Augment medical devices because preassembled Femoral Augment screws are missing their threads, preventing proper fixation. The recall affects 1771 units distributed nationwide.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is an FDA Class II recall of an orthopedic implant component with a structural defect (missing thread on preassembled screw) that prevents proper fixation. While no injuries or deaths have been reported, the defect creates a substantial risk-of-harm to patients, fitting the criteria for a risk-of-harm product where injury has not yet been reported.

Plain-English summary

Waldemar Link GmbH & Co. KG is recalling Tibial Augment medical devices used in knee replacement surgery. The recall involves 30 different item numbers representing different sizes and configurations of tibial augments, with a total of 1771 units affected.

The recalled devices were delivered with preassembled Femoral Augment screws that are missing their threads. A screw missing its thread cannot properly fasten, which means the augment component cannot be securely fixed to the tibial baseplate as intended, potentially compromising the stability of the implant.

The affected devices were distributed nationwide to healthcare facilities in 17 states: Alabama, Arizona, California, Colorado, Florida, Georgia, Indiana, Illinois, Kansas, Louisiana, Maryland, Missouri, Nevada, Ohio, Texas, Virginia, and Wisconsin. All lots manufactured up until March 1, 2025 are included in this recall.

Patients with implanted components from this recall and healthcare facilities with affected inventory should contact Waldemar Link for further guidance. Healthcare providers should verify whether they received affected lots using the provided item numbers and UDI-DI codes, and take appropriate corrective action.

The recalled product

Product
Tibial Augment; Item Numbers: (1) 880-331/11 (Sz. 1-2 - cemented x-sm), (2) 880-331/12 (Sz. 1-2 - cemented sm), (3) 880-331/13 (Sz. 1-2 - cemented md), (4) 880-331/21 (Sz. 1-2 - cemented lg), (5) 880-331/22 (Sz. 1-2 - cemented x-lg), (6) 880-331/23 (Sz. 1-2 - cemented xx-lg), (7)
Manufacturer
Waldemar Link GmbH & Co. KG (Mfg Site)
Category
Medical Device — Orthopedic Implant
Hazard
  • structural-defect
  • implant-failure-risk

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • Item Number/UDI-DI: (1) 880-331/11 (04026575258192)
  • (2) 880-331/12 (04026575258208)
  • (3) 880-331/13 (04026575258215)
  • (4) 880-331/21 (04026575258222)
  • (5) 880-331/22 (04026575258246)
  • (6) 880-331/23 (04026575258253)
  • (7) 880-333/11 (04026575258260)
  • (8) 880-333/12 (04026575258277)
  • (9) 880-333/13 (04026575258284)
  • (10) 880-333/21 (04026575258291)
  • (11) 880-333/22 (04026575258307)
  • (12) 880-333/23 (04026575258314)
  • (13) 880-335/11 (04026575258321)
  • (14) 880-335/12 (04026575258338)
  • (15) 880-335/13 (04026575258345)
  • (16) 880-335/21 (04026575258352)
  • (17) 880-335/22 (04026575258369)
  • (18) 880-335/23 (04026575258376)
  • (19) 880-337/11 (04026575258383)
  • (20) 880-337/12 (04026575258390)

Distribution

Distributed nationwide across the United States.

Related recalls

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