The Recall Desk
HighFDA (Devices)·Z-1699-2025·Announced 2025-05-07

Distal Femoral Augment Screw Missing Thread Defect

Waldemar Link is recalling 1,180 Distal Femoral Augments used in knee replacement surgery because the preassembled augment screw is missing its securing thread, which could prevent proper attachment during implantation.

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 structural defect in a Class II medical device—a screw component missing its securing thread on a knee replacement implant. While the defect creates a clear risk of implant failure, the source text reports no illnesses or injuries, so the maximum score is 3 per the rubric.

Plain-English summary

Waldemar Link GmbH & Co. KG is recalling 1,180 Distal Femoral Augments, surgical implant components used in knee replacement procedures. These devices are supplied with a preassembled femoral augment screw that was manufactured without its securing thread.

The missing screw thread could prevent the augment from being securely attached during surgical implantation, creating a risk of implant failure. The FDA has classified this as a Class II recall.

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

Healthcare providers using these devices should contact Waldemar Link or the FDA with any questions. Patients who received these implants should speak with their surgeon to determine if their device was among those recalled.

The recalled product

Product
Distal Femoral Augment; Item Numbers: (1) 880-300/11 (Sz. 0 - cemented sm), (2) 880-300/21 (Sz. 0 - cemented lg), (3) 880-301/11 (Sz. 1-2 - cemented sm), (4) 880-301/21 (Sz. 1-2 - cemented lg), (5) 880-303/11 (Sz. 3-4 - cemented sm), (6) 880-303/12 (Sz. 3-4 - cemented md), (7) 88
Manufacturer
Waldemar Link GmbH & Co. KG (Mfg Site)
Category
Medical Device — Orthopedic / Knee Implant Component
Hazard
  • missing-screw-thread
  • 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) 880-300/11 (04026575284931)
  • (2) 880-300/21 (04026575257102)
  • (3) 880-301/11 (04026575257133)
  • (4) 880-301/21 (04026575257140)
  • (5) 880-303/11 (04026575257171)
  • (6) 880-303/12 (04026575257188)
  • (7) 880-303/21 (04026575257195)
  • (8) 880-303/22 (04026575257201)
  • (9) 880-305/11 (04026575257256)
  • (10) 880-305/12 (04026575257263)
  • (11) 880-305/21 (04026575257270)
  • (12) 880-305/22 (04026575257287)
  • (13) 880-307/11 (04026575257379)
  • (14) 880-307/12 (04026575257386)
  • (15) 880-307/21 (04026575257393)
  • (16) 880-307/22 (04026575257409)
  • (17) 880-309/11 (04026575257454)
  • (18) 880-309/12 (04026575257461)
  • (19) 880-309/21 (04026575257478)
  • manufactured up until 03/01/2025.

Distribution

Distributed nationwide across the United States.

Related recalls

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