Quick Facts at a Glance
- Recall Date
- January 12, 2026
- Hazard Level
- HIGH
- Brand
- Waldemar Link
- 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
- Product type
- Endo-Model Replacement Plateau Component
- Model numbers
- 15-0027/16, UDI-DI: 04026575432134
- 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 a component used in orthopedic implants. It is used by surgeons under medical protocols.
Why This Is Dangerous
A longitudinal fracture could cause the bushing to detach from the screw shaft, potentially affecting implant stability.
Industry Context
This recall is not part of a broader industry pattern at this time.
Real-World Impact
Hospitals and patients may face delays in care and additional follow-up for implant safety.
Practical Guidance
How to identify if yours is affected
- Check item number 15-0027/16 on the device label
Where to find product info
Check device packaging and labeling for item number, UDI, and serial numbers
What timeline to expect
Not specified in public notices
If the manufacturer is unresponsive
- Escalate to the FDA or your healthcare provider
- File a report with the hospital risk management department
How to prevent similar issues
- Verify device recall status before performing implants
- Ensure implants have updated components from the manufacturer
- Keep recall notices on file for future reference
Documentation advice
Keep copies of the recall notice, labeling, serial numbers, and all correspondence with the manufacturer.
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Product Details
Model numbers: Item Number 15-0027/16; UDI-DI 04026575432134; Serial/Lot Numbers: 2550412, 2550413, 2549228; Sold worldwide including US NJ and the countries Belarus, Canada, Switzerland, Colombia, Germany, Spain, United Kingdom, Hungary, India, Italy, Netherlands, Romania, Saudi Arabia; Quantity: 3 units; Price: Unknown; When sold: Unknown
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Distribution: Worldwide including New Jersey (US) and multiple countries
- Hazard: Detachment of bushing from screw shaft due to longitudinal fracture
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Safety Guide
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