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: 15-0027/15, UDI-DI: 04026575432127, Serial/Lot Number: 2549190
- 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
Endo-Model Replacement Plateau is an implant component used in surgical procedures. The recall centers on a mechanical defect that could compromise implant integrity.
Why This Is Dangerous
A longitudinal fracture can cause the plateau screw bushing to detach from the screw shaft, risking device failure.
Industry Context
This recall is not described as part of a broader industry pattern in the notice.
Real-World Impact
Affected patients may require medical evaluation and potential corrective actions. The notice specifies immediate cessation of use.
Practical Guidance
How to identify if yours is affected
- Check Item Number 15-0027/15
- Review Serial/Lot Number 2549190
Where to find product info
On device packaging and accompanying documentation; recall letter; FDA recall page
What timeline to expect
Not specified in the recall notice
If the manufacturer is unresponsive
- Escalate to FDA recall contacts or healthcare provider
- Document all communications and seek assistance from medical professional
How to prevent similar issues
- Always confirm device identifiers during implantation or follow-up
- Review recall notices promptly with healthcare providers
- Ask for manufacturer communications in writing when purchasing implants
Documentation advice
Keep recall letter, device labels, serial numbers, and all communications with providers and the manufacturer
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Product Details
Model numbers: Item Number 15-0027/15; UDI-DI 04026575432127; Serial/Lot Number 2549190. Sold worldwide to healthcare providers, including US NJ and a list of countries. When sold: Unknown. Price: Unknown.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Serial/Lot Number 2549190
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