The Recall Desk
Agency classClass IIOur severity: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.

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 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)…
Manufacturer
Waldemar Link GmbH & Co. KG (Mfg Site)
Category
Medical Device — Orthopedic Implant
Hazard
Affected units
1,771

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.

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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