Quick Facts at a Glance
- Recall Date
- January 12, 2026
- Hazard Level
- HIGH
- Brand
- Waldemar Link
- 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
- Product type
- Orthopedic Implant
- Model numbers
- Item Number: 15-8030/12, UDI-DI: 04026575048151
- 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
Endo-Model Replacement Plateau components are used in orthopedic implants to secure or position a plateau screw in specific device configurations. They are intended for surgical use under professional care.
Why This Is Dangerous
A longitudinal fracture may detach the bushing from the screw shaft, potentially compromising implant integrity and function.
Industry Context
This recall is not described as part of a broader industry pattern in the provided information.
Real-World Impact
The recall affects a small number of units (4) and may require medical evaluation, surgical planning, and potential device replacement coordinated by healthcare providers.
Practical Guidance
How to identify if yours is affected
- Confirm Item Number 15-8030/12.
- Check UDI-DI 04026575048151 on device documentation.
- Consult your surgeon or hospital's procurement department for guidance.
Where to find product info
Device packaging, implant records, and facility procurement notes contain identifiers; the FDA recall page provides official information.
What timeline to expect
Refunds or replacements are not specifically timed in the recall; expect hospital coordination with the manufacturer for remedies.
If the manufacturer is unresponsive
- Coordinate with the treating facility.
- File a complaint with the appropriate regulatory authority if needed.
How to prevent similar issues
- Request and document the device's UDI during implantation.
- Verify recall status before any implant procedure.
- Maintain open communication with the implant center and surgeon.
Documentation advice
Keep a copy of the recall notice, device identifiers, serial numbers, and all correspondence with health care providers and manufacturers.
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Product Details
Item Number: 15-8030/12. UDI-DI: 04026575048151. Serial numbers: 250721/0194; 250721/0212; 250721/0211; 250721/0209. Sold to hospitals and clinics worldwide, including the US state of New Jersey. Quantity recalled: 4 units. Distribution: Worldwide; Belarus, Canada, Switzerland, Colombia, Germany, Spain, United Kingdom, Hungary, India, Italy, Netherlands, Romania, Saudi Arabia. Price: Unknown.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Worldwide distribution including US NJ
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Safety Guide
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