The Recall Desk
HighFDA (Devices)·Z-1379-2022·Announced 2022-07-20

Tibial Prosthesis Component Recalled for Intraoperative Screw Loosening Defect

Tibial prosthesis components may have blind screws that cannot be loosened during surgery, potentially requiring surgical procedure changes and extended operative time.

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 is a Class II medical device recall involving a mechanical defect that creates risk of intraoperative complications. No illnesses or injuries have been reported. Per the severity rubric, mechanical defects in risk-of-harm medical devices where no injury has been reported score as High (3).

Plain-English summary

Waldemar Link GmbH & Co. KG is recalling certain modular tibial (shin bone) prosthesis components used in orthopedic joint replacement surgery. Approximately 3,785 units of three models are affected: Model W 16-2817/02 (Small), Model W 16-2817/05 (Medium), and Model W 16-2817/07 (Large).

The recalled components have blind screws that may not be possible to loosen during surgery. If this defect is encountered intraoperatively, it may lead to prolonged surgery or require the surgeon to change the planned surgical approach.

The components were distributed both domestically and internationally. Healthcare providers with these components in inventory should verify their stock against the affected model numbers and serial/lot numbers (201002/1683, 211025/1543, 210202/0275, 210302/0308, 210314/1872, 201002/1687) and follow the manufacturer's guidance regarding replacement or return.

The recalled product

Product
Tibial Component. orthopedic prosthesis. Model Nos: Small, W 16-2817/02 Medium, W 16-2817/05 Large, W 16-2817/07
Manufacturer
Waldemar Link GmbH & Co. KG (Mfg Site)
Category
Medical Device — Orthopedic Prosthesis
Hazard
Affected units
3,785

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 (4)

  • UDI-DI: 04026575359202 Small
  • W
  • 04026575359219 Medium
  • 04026575359226 Large

Distribution

Distributed in 15 states:

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 →

Related recalls

Same manufacturer · Waldemar Link GmbH & Co. KG (Mfg Site)

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Same hazard · screw defect

See all →