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
- Unknown
- 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
- Implant Component
- Model numbers
- Item Number: 15-0027/11, UDI-DI: 04026575431953, Serial/Lot Number: 2549126, 2549127
- Sold at
- Unknown
- 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 a component used in orthopedic implant systems. The device is intended to secure a plateau screw in the implant construct.
Why This Is Dangerous
A longitudinal fracture could cause the bushing to detach from the screw shaft, potentially compromising implant integrity.
Industry Context
This recall is not part of a broader industry pattern at this time.
Real-World Impact
Immediate halt in use is required. No injuries reported, but the risk could affect implant stability.
Practical Guidance
How to identify if yours is affected
- Verify Item Number 15-0027/11
- Check Serial Numbers 2549126 and 2549127
Where to find product info
UDI labels on the device packaging; documentation from healthcare providers; FDA recall page linked in the notice
What timeline to expect
Remedy and replacement/reimbursement details will be provided via manufacturer communication in the recall process
If the manufacturer is unresponsive
- Consult your healthcare provider
- Contact FDA recall resources for guidance
How to prevent similar issues
- Verify device components before use in surgical procedures
- Keep recall communications and serial information organized
- Ask for replacement parts from the manufacturer if a similar plate is provided
Documentation advice
Document recall notice, serial numbers, and any correspondence with the manufacturer or healthcare provider
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Product Details
Product: Endo-Model Replacement Plateau. Item Number: 15-0027/11. UDI-DI: 04026575431953. Serial/Lot Numbers: 2549126, 2549127. Quantity: 2 units. Distribution: Worldwide with US nationwide distribution in New Jersey. Countries: Belarus, Canada, Switzerland, Colombia, Germany, Spain, United Kingdom, Hungary, India, Italy, Netherlands, Romania, Saudi Arabia. Manufacturer: Waldemar Link GmbH & Co. KG.
Reported Incidents
No injuries or incidents have been reported in the announced data.
Key Facts
- Serial/Lot Numbers 2549126, 2549127
- Distributed worldwide including NJ, USA
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Safety Guide
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