HIGH

Waldemar Link Endo-Model Replacement Plateau Recall for Detachment Risk (2026)

Waldemar Link recalled 1 unit of Endo-Model Replacement Plateau worldwide, including the United States in New Jersey. The device could detach its bushing from the screw shaft because of a longitudinal fracture. Clinicians and patients should stop using the device and await manufacturer instructions.

Quick Facts at a Glance

Recall Date
January 12, 2026
Hazard Level
HIGH
Brand
Waldemar Link GmbH & Co. KG
Category
Health & Personal Care
Sold At
Multiple Retailers
Geographic Scope
1 states
At-Risk Groups
GENERAL

Hazard Information

The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture.

What You Should Do

Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Waldemar Link GmbH & Co. KG (Mfg Site) or your healthcare provider for instructions. Notification method: Letter

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About This Product

This is an orthopedic implant component used in surgical procedures to secure plates with screws during reconstructive operations.

Why This Is Dangerous

If a longitudinal fracture occurs, the bushing could detach from the screw shaft, potentially compromising implant stability and patient safety.

Industry Context

This recall is not part of a broader industry pattern.

Real-World Impact

The recall creates an immediate cessation of use and coordination with clinicians for potential replacement, affecting surgical planning and patient safety.

Practical Guidance

How to identify if yours is affected

  1. Inspect packaging and device for Item Number 15-2835/12
  2. Check UDI-DI 04026575316564 on labeling
  3. Confirm Serial/Lot Number 241210/1809
  4. If matching, isolate the device and contact the manufacturer

Where to find product info

Identifiers are printed on the device packaging and on the device body where applicable

What timeline to expect

Remedy processing can take 4-8 weeks

If the manufacturer is unresponsive

  • Document communications
  • File consumer protection complaints
  • Consult legal counsel if necessary

How to prevent similar issues

  • Verify UDI and serial numbers before use in any device
  • Source devices from authorized distributors
  • Monitor recalls through FDA enforcement reports

Documentation advice

Keep receipts, photos of the device, and all correspondence with the manufacturer and clinicians

Product Details

Item Number: 15-2835/12 UDI-DI: 04026575316564 Serial/Lot Number: 241210/1809 Sold Worldwide; US distribution in New Jersey Price: Unknown

Reported Incidents

No injuries or incidents have been reported.

Key Facts

  • 1 unit recalled
  • Model 15-2835/12, UDI-DI 04026575316564, Serial/Lot 241210/1809
  • Global distribution including US NJ and multiple countries
  • Recall date 2026-01-12; status ACTIVE
  • Remedy: Stop use immediately; follow manufacturer instructions
View Original Recall on FDA - Medical Devices

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Safety Guide

Not sure what to do next? Our guide walks you through the process step by step.

Read: What to Do When You Find a Recalled Product

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Safety Assessment

Risk LevelHIGH
Severity Score
8/ 10
Affected Groups
GENERAL
Injury Types
LACERATIONCRUSHINGOTHER

Product Classification

Product TypeEndo-Model Replacement Plateau (orthopedic implant component)
Sold At
Multiple Retailers

Product Details

Model Numbers
15-2835/12
04026575316564
241210/1809
Affected States
ALL
Report Date
March 18, 2026
Recall Status
ACTIVE

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