The Recall Desk
Agency classClass IIOur severity:SevereFDA (Devices)·Z-1701-2025·Announced 2025-05-07

L-Shaped Femoral Augment with Missing Screw Thread

Waldemar Link GmbH & Co. KG is recalling L-Shaped Femoral Augments because the preassembled femoral augment screw was missing its thread. The defect could affect the device's structural integrity during orthopedic surgery.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: This is an FDA Class II recall of a structural medical device (orthopedic femoral augment) where the preassembled screw is missing its thread. The defect directly compromises the device's ability to function correctly during implantation, creating risk of implant failure or inadequate fixation during surgery, which meets the Severe criterion for structural device defects.

Plain-English summary

Waldemar Link GmbH & Co. KG is recalling L-Shaped Femoral Augments (Item Numbers 880-320/12, 880-320/22, 880-321/12, 880-321/22, 880-323/13, 880-323/23, 880-325/13, 880-325/23, 880-327/13, 880-327/23, 880-329/13, and 880-329/23) used in orthopedic surgery. The devices were delivered with a preassembled femoral augment screw that was missing its thread.

A total of 441 units were distributed nationwide to medical facilities in Alabama, Arizona, California, Colorado, Florida, Georgia, Indiana, Illinois, Kansas, Louisiana, Maryland, Missouri, Nevada, Ohio, Texas, Virginia, and Wisconsin. All lots manufactured up to March 1, 2025, are affected.

If you received or used one of these devices, contact Waldemar Link GmbH & Co. KG or the FDA to report the defect. Do not use affected units for surgery until you confirm the device integrity with the manufacturer.

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
Affected units
441

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.

The notice also names 17 states specifically:

Part of a larger recall action

This product is one of 4 recalled by Waldemar Link GmbH & Co. KG (Mfg Site) under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 4 products in this recall →

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