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, PREGNANT, PREGNANT
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 screw system
- Model numbers
- Item Number: 15-8521/15, UDI-DI: 04026575383283, Serial/Lot Number: 250805/0020, 250805/0021, 250805/0023, 250805/0024
- 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 spinal fixation implant component. It is used in surgeries to stabilize the spine.
Why This Is Dangerous
A longitudinal fracture could cause the bushing to detach from the screw shaft, potentially compromising fixation.
Industry Context
This recall is not identified as part of a broader industry pattern in the provided data.
Real-World Impact
Implant component failure could necessitate surgical intervention or revision, with patient safety implications.
Practical Guidance
How to identify if yours is affected
- Verify item number 15-8521/15
- Inspect serial numbers 250805/0020 to 250805/0024
Where to find product info
UDI labels on the device packaging and accompanying documentation
What timeline to expect
No remediation timeline provided; follow manufacturer instructions via recall notice
If the manufacturer is unresponsive
- Escalate to the hospital’s procurement or risk management department
- CONTACT regulatory bodies like the FDA if the manufacturer is unresponsive
How to prevent similar issues
- Ensure devices have current recalls listed by FDA
- Verify UDI during procurement
- Maintain updated medical device recall databases
Documentation advice
Document serial numbers, dates, communications with manufacturer, and any adverse events
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Product Details
Brand: Waldemar Link GmbH & Co. KG. Product: Endo-Model Replacement Plateau. Item Number: 15-8521/15. UDI-DI: 04026575383283. Serial/Lot Numbers: 250805/0020, 250805/0021, 250805/0023, 250805/0024. Quantity: 4 units. Sold Worldwide with NJ distribution in the US and in Belarus, Canada, Switzerland, Colombia, Germany, Spain, United Kingdom, Hungary, India, Italy, Netherlands, Romania, Saudi Arabia. Recall Date: 2026-01-12. Status: Active.
Reported Incidents
No injuries or incidents have been reported in the provided data.
Key Facts
- Serial numbers 250805/0020 to 250805/0024
- Worldwide distribution with NJ in US
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Safety Guide
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