The Recall Desk
HighFDA (Devices)·Z-1700-2025·Announced 2025-05-07

Posterior Femoral Augment Surgical Implant with Missing Screw Thread Recalled

Waldemar Link is recalling Posterior Femoral Augment orthopedic implants distributed nationwide due to missing threads on preassembled screws. Patients should contact their surgeon immediately.

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 a Class II FDA recall of an orthopedic surgical implant with a structural defect (missing thread on preassembled screw). The source explicitly states no illnesses or injuries have been reported, and the hazard is theoretical rather than materialized, placing it at Score 3 (High) as a risk-of-harm product where injury has not yet been reported.

Plain-English summary

Waldemar Link GmbH & Co. KG is recalling Posterior Femoral Augment components, which are surgical implants used in knee replacement procedures. The defect involves preassembled femoral augment screws that were delivered missing their threads.

The recall affects 908 units distributed nationwide across 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 the recall.

The FDA has classified this as a Class II recall. Patients who have received one of these implants should contact their orthopedic surgeon or healthcare provider immediately to discuss this matter.

No illnesses or injuries have been reported to date.

The recalled product

Product
Posterior Femoral Augment; Item Numbers: (1) 880-310/11 (Sz. 0 - cemented sm), (2) 880-310/21 (Sz. 0 - cemented lg), (3) 880-311/11 (Sz. 1-2 - cemented sm), (4) 880-311/21 (Sz. 1-2 - cemented lg), (5) 880-313/11 (Sz. 3-4 - cemented sm), (6) 880-313/12 (Sz. 3-4 - cemented md), (7)
Manufacturer
Waldemar Link GmbH & Co. KG (Mfg Site)
Category
Medical Device — Orthopedic Implant
Hazard
  • structural-defect
  • device-defect

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) 880-310/11 (04026575257539)
  • (2) 880-310/21 (04026575257546)
  • (3) 880-311/11 (04026575257607)
  • (4) 880-311/21 (04026575257584)
  • (5) 880-313/11 (04026575257621)
  • (6) 880-313/12 (04026575257645)
  • (7) 880-313/21 (04026575257669)
  • (8) 880-313/22 (04026575257690)
  • (9) 880-315/11 (04026575257768)
  • (10) 880-315/12 (04026575257775)
  • (11) 880-315/21 (04026575257782)
  • (12) 880-315/22 (04026575257799)
  • (13) 880-317/11 (04026575257843)
  • (14) 880-317/12 (04026575257850)
  • (15) 880-317/21 (04026575257867)
  • (16) 880-317/22 (04026575257881)
  • (17) 880-319/11 (04026575257942)
  • (18) 880-319/12 (04026575257959)
  • (19) 880-319/21 (04026575257966)
  • manufactured up until 03/01/2025.

Distribution

Distributed nationwide across the United States.

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