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
- Orthopedic Implant Component
- Model numbers
- Item Number: 15-8521/11, UDI-DI: 04026575383245, Serial/Lot Numbers: 250728/2220, 250728/2222, 250728/2223, 250728/2224, 250728/2225, 250728/2226 +1 more
- 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
The Endo-Model Replacement Plateau is an orthopedic implant component used in surgical procedures to stabilize certain bone segments. Implants like this are critical to patient rehabilitation and require precise integration with surrounding hardware.
Why This Is Dangerous
A longitudinal fracture could cause the plateau screw bushing to detach from the screw shaft, creating a mechanical failure risk that may necessitate revision surgery.
Industry Context
This recall is not described as part of a broader industry pattern in the notice.
Real-World Impact
The recall affects 7 implanted devices distributed worldwide. Patients may require evaluation and possible surgery to address component detachment.
Practical Guidance
How to identify if yours is affected
- Verify item number 15-8521/11 on the device or packaging.
- Review Serial/Lot numbers 250728/2220 through 250728/2227.
Where to find product info
Identifiers appear on device labeling, packaging, or accompanying documentation.
What timeline to expect
Manufacturer guidance will outline removal or replacement timelines; recalls of implants typically involve coordinated medical scheduling.
If the manufacturer is unresponsive
- Escalate to the healthcare provider coordinating the implant care
- Contact the manufacturer for instruction
- Consult FDA or corresponding regulatory body if the device requires urgent action
How to prevent similar issues
- For future purchases, verify UDI and serial numbers
- Follow regulatory recall communications promptly
- Ensure implants are maintained and stored per manufacturer guidelines
Documentation advice
Document recall communications, device identifiers, and notes from healthcare providers; retain all packaging and documentation for records.
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Product Details
Item Number: 15-8521/11; UDI-DI: 04026575383245; Serial/Lot Numbers: 250728/2220, 250728/2222, 250728/2223, 250728/2224, 250728/2225, 250728/2226, 250728/2227; Quantity: 7 units (OUS only); Sold worldwide including US NJ; Recall date: 2026-01-12; Status: ACTIVE; Manufacturer: Waldemar Link GmbH & Co. KG; Recall URL: https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-1519-2026; Category: Medical Devices.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- 7 units recalled (OUS only)
- Worldwide distribution; US NJ distribution
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Safety Guide
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