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, PREGNANT, PETS
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
- Implant Replacement Plateau
- Model numbers
- Item Number 15-8521/09, UDI-DI: 04026575383238, Serial/Lot Numbers: 250728/0038-0045
- 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 used in orthopedic implants as part of plate systems. Buyers seek stability and compatibility with screw shafts.
Why This Is Dangerous
A longitudinal fracture could detach the bushing from the screw shaft, threatening implant stability.
Industry Context
This recall is not clearly stated as part of a broader industry pattern.
Real-World Impact
Immediate cessation of device use is required; patients may experience delays in treatment while navigating replacement options.
Practical Guidance
How to identify if yours is affected
- Check Item Number 15-8521/09
- Inspect Serial Numbers 250728/0038 to 250728/0045
Where to find product info
UDI and serial numbers on device packaging and official recall notices
What timeline to expect
Refunds/replacements depend on manufacturer guidance; expect weeks to months
If the manufacturer is unresponsive
- Document all communications
- Escalate to patient advocacy or regulatory bodies if no response
How to prevent similar issues
- Verify device compatibility before procedures
- Ensure proper screw-bushing coupling
- Maintain updated patient records for implants
Documentation advice
Keep recall notices, serial numbers, and communications with healthcare providers
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Reported Incidents
No specific injuries or incidents are described in the provided data. Hazard level is HIGH based on the potential risk.
Key Facts
- Worldwide distribution including NJ, Belarus, Canada, Switzerland, Colombia, Germany, Spain, UK, ...
- High hazard level
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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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