The Recall Desk
SevereFDA (Devices)·Z-1702-2025·Announced 2025-05-07

Tibial Augment devices recalled for missing screw thread

Waldemar Link GmbH & Co. KG is recalling Tibial Augment devices distributed nationwide because preassembled Femoral Augment screws were delivered missing their threads.

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 for a structural orthopedic implant with a manufacturing defect (missing thread on preassembled screw) that directly affects device integrity and function. Although no injuries are explicitly reported in the source, the defect poses a significant risk of harm to patients who have already received the implant, meeting the Severe threshold.

Plain-English summary

Waldemar Link GmbH & Co. KG is recalling Tibial Augment devices across multiple item numbers and sizes. The devices were delivered with a preassembled Femoral Augment screw that was missing its thread, which could compromise the structural integrity and stability of the implant during or after surgical use.

Approximately 1,771 units have been distributed nationwide in the following states: AL, AZ, CA, CO, FL, GA, IN, IL, KS, LA, MD, MO, NV, OH, TX, VA, and WI. The recall applies to all lots manufactured up until March 1, 2025.

Patients who have received this device should contact their surgeon or healthcare provider immediately. Healthcare facilities and distributors are advised to quarantine affected units and review patient records to identify those who may have received an affected device.

The recalled product

Product
Tibial Augment; Item Numbers: (1) 880-331/11 (Sz. 1-2 - cemented x-sm), (2) 880-331/12 (Sz. 1-2 - cemented sm), (3) 880-331/13 (Sz. 1-2 - cemented md), (4) 880-331/21 (Sz. 1-2 - cemented lg), (5) 880-331/22 (Sz. 1-2 - cemented x-lg), (6) 880-331/23 (Sz. 1-2 - cemented xx-lg), (7)
Manufacturer
Waldemar Link GmbH & Co. KG (Mfg Site)
Category
Medical Device — Orthopedic Implant
Hazard
  • structural-defect
  • manufacturing-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) 880-331/11 (04026575258192)
  • (2) 880-331/12 (04026575258208)
  • (3) 880-331/13 (04026575258215)
  • (4) 880-331/21 (04026575258222)
  • (5) 880-331/22 (04026575258246)
  • (6) 880-331/23 (04026575258253)
  • (7) 880-333/11 (04026575258260)
  • (8) 880-333/12 (04026575258277)
  • (9) 880-333/13 (04026575258284)
  • (10) 880-333/21 (04026575258291)
  • (11) 880-333/22 (04026575258307)
  • (12) 880-333/23 (04026575258314)
  • (13) 880-335/11 (04026575258321)
  • (14) 880-335/12 (04026575258338)
  • (15) 880-335/13 (04026575258345)
  • (16) 880-335/21 (04026575258352)
  • (17) 880-335/22 (04026575258369)
  • (18) 880-335/23 (04026575258376)
  • (19) 880-337/11 (04026575258383)
  • (20) 880-337/12 (04026575258390)

Distribution

Distributed nationwide across the United States.

Related recalls

Same category