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

Posterior Femoral Augment with Missing Screw Thread Recalled

Waldemar Link is recalling Posterior Femoral Augments used in knee surgery because some units were delivered with a preassembled screw missing its thread, which could compromise surgical fixation.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: This is an FDA Class II recall involving an orthopedic surgical implant with a structural defect (missing thread on a critical fastener) that could lead to implant failure and require revision surgery. While no reported injuries or hospitalizations are stated in the source, the potential for serious harm from implant failure in a load-bearing knee prosthesis application meets the criteria for Severe.

Plain-English summary

Waldemar Link GmbH & Co. KG is recalling Posterior Femoral Augments (Item Numbers 880-310/11 through 880-319/22) due to a manufacturing defect. The devices were delivered with a preassembled Femoral Augment screw that was missing its thread.

A screw missing its thread cannot function as intended to secure the augment during knee replacement surgery. This defect could result in implant instability or failure.

The recall affects 908 units 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 of the LINK SymphoKnee Femoral Augments listed were manufactured up until March 1, 2025.

Healthcare providers who have received affected units should cease use immediately and contact Waldemar Link for instructions on device return or replacement.

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 / Knee Surgery
Hazard
  • defective-screw
  • implant-failure
  • structural-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.

Related recalls

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