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
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- Waldemar Link GmbH & Co. KG
- Product type
- Endo-Model Replacement Plateau (orthopedic implant component)
- Model numbers
- 15-2835/12, 04026575316564, 241210/1809
- Sold at
- Multiple Retailers
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
January 12, 2026
Reported by FDA DEVICE
March 18, 2026
RecallRadar source check
April 18, 2026
Consumer action
Use the official remedy and keep documentation.
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
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
- Inspect packaging and device for Item Number 15-2835/12
- Check UDI-DI 04026575316564 on labeling
- Confirm Serial/Lot Number 241210/1809
- 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
- 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
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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
- Global distribution including US NJ and multiple countries
- Recall date 2026-01-12; status ACTIVE
- Remedy: Stop use immediately; follow manufacturer instructions
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Safety Guide
Not sure what to do next? Our guide walks you through the process step by step.
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