The Recall Desk
HighFDA (Devices)·Z-1701-2025·Announced 2025-05-07

Knee Replacement Femoral Augment Screw Delivered Missing Thread

Waldemar Link femoral augment screws for knee replacement surgery were distributed preassembled but missing the thread needed for proper attachment. Affected units shipped nationwide to 17 states.

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 FDA Class II recall involves a structural defect (missing screw thread) in an orthopedic implant. Per the FDA severity rubric, this constitutes a risk-of-harm product where no injury has been reported, corresponding to High severity.

Plain-English summary

Waldemar Link GmbH & Co. KG is recalling L-Shaped Femoral Augments used in knee replacement surgery. The recalled devices include 12 product variants covering sizes 0 through 9-10. A total of 441 units were distributed.

The devices were delivered with a preassembled femoral augment screw that was missing its thread. The thread is essential for secure attachment of the screw during surgical implantation.

The affected implants were distributed nationwide to hospitals and surgical centers in 17 U.S. states: Alabama, Arizona, California, Colorado, Florida, Georgia, Indiana, Illinois, Kansas, Louisiana, Maryland, Missouri, Nevada, Ohio, Texas, Virginia, and Wisconsin. The recall applies to all lots manufactured up until March 1, 2025.

Patients who received this implant or whose knee replacement surgery is scheduled should contact their healthcare provider immediately for guidance. Healthcare providers should cease use of the recalled devices and verify their inventory against the provided item numbers and UDI codes.

The recalled product

Product
L-Shaped Femoral Augment; Item Numbers: (1) 880-320/12 (Sz. 0 - cemented sm), (2) 880-320/22 (Sz. 0 - cemented lg), (3) 880-321/12 (Sz. 1-2 - cemented sm), (4) 880-321/22 (Sz. 1-2 - cemented lg), (5) 880-323/13 (Sz. 3-4 - cemented sm), (6) 880-323/23 (Sz. 3-4 - cemented lg), (7)
Manufacturer
Waldemar Link GmbH & Co. KG (Mfg Site)
Category
Medical Device — Orthopedic Implant
Hazard
  • device-defect
  • assembly-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 (12)

  • Item Number/UDI-DI: (1) 880-320/12 (04026575258048)
  • (2) 880-320/22 (04026575258055)
  • (3) 880-321/12 (04026575258062)
  • (4) 880-321/22 (04026575258079)
  • (5) 880-323/13 (04026575258086)
  • (6) 880-323/23 (04026575258109)
  • (7) 880-325/13 (04026575258123)
  • (8) 880-325/23 (04026575258147)
  • (9) 880-327/13 (04026575258154)
  • (10) 880-327/23 (04026575258161)
  • (11) 880-329/13 (04026575258178)
  • manufactured up until 03/01/2025.

Distribution

Distributed nationwide across the United States.

Related recalls

Same category