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 Implant Component
- Model numbers
- Item Number: 15-0027/12, UDI-DI: 04026575431960, Serial/Lot Number: 2549036
- 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
The Endo-Model Replacement Plateau is an orthopedic implant component used in surgical procedures. It is intended to integrate with other implant parts to restore function.
Why This Is Dangerous
If the plateau screw bushing detaches from the screw shaft due to a longitudinal fracture, the implant could lose stability and function.
Industry Context
This recall is not described as part of a broader industry pattern in the provided data.
Real-World Impact
The recall indicates potential implant failure risk. No injuries have been reported, and the recall is active. Patients with this component should consult their surgeon.
Practical Guidance
How to identify if yours is affected
- Locate the device labeling for Item Number 15-0027/12
- Inspect the UDI-DI 04026575431960
- Check Serial/Lot Number 2549036
- Confirm this device is within the recall scope
Where to find product info
Identifiers appear on device labeling, packaging, and recall notification letters.
What timeline to expect
No specific timeline provided for replacement or refunds.
If the manufacturer is unresponsive
- Escalate to the regulatory body or seek a patient advocate for assistance.
- Document all communications with the manufacturer and healthcare providers.
How to prevent similar issues
- Always verify device recall status before implantation or reuse.
- Ask healthcare providers about device lineage and recall history.
- Keep copies of recall letters and contact information for future reference.
Documentation advice
Keep recall notices, medical records, device labels, and all correspondence with the manufacturer and healthcare providers.
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Product Details
Model numbers in recall: Item Number 15-0027/12; UDI-DI 04026575431960; Serial/Lot Number 2549036. Distribution: Worldwide, including US NJ and the countries Belarus, Canada, Switzerland, Colombia, Germany, Spain, United Kingdom, Hungary, India, Italy, Netherlands, Romania, Saudi Arabia. Quantity: 1 unit.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- 1 unit recall (OUS)
- Worldwide distribution including US NJ
- No injuries reported to date
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Safety Guide
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