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
- Implant Component
- Model numbers
- 16-2840/05
- 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 21, 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
This is a surgically implanted component used in the Endo-Model SL system with a plateau screw design. It is intended to secure a connection within an implant construct.
Why This Is Dangerous
A longitudinal fracture can detach the bushing from the screw shaft, potentially compromising implant stability and function.
Industry Context
This recall is not described as part of a broader industry pattern.
Real-World Impact
Clinicians may need to stop surgeries using these components and arrange for replacement parts or re-implantation. Patients may require additional procedures to ensure implant integrity.
Practical Guidance
How to identify if yours is affected
- Check Item Number 16-2840/05 on the device or accompanying documentation
- Review Serial/Lot Numbers for listed entries (e.g., 250513/2083, 250513/2108, 251013/3252)
- Look for recall notification mailed to facilities or patients
Where to find product info
UDI-DI on packaging/label; Item Number on product label; recall notice from Waldemar Link
What timeline to expect
Recall notices will guide replacement or repair; timelines vary by facility
If the manufacturer is unresponsive
- Escalate to hospital risk management
- Contact Waldemar Link recall channels
- File a report with the FDA if advised by authorities
How to prevent similar issues
- Only use components from approved suppliers
- Verify device compatibility with surgical plan
- Maintain an updated inventory of affected items for recall checks
Documentation advice
Keep recall notice, record Item Number, UDI-DI, and all serial numbers; save communications with manufacturer; photograph device labels
Get instant alerts for Health & Personal Care recalls
Be the first to know. Free instant alerts to your inbox.
Product Details
Item Number: 16-2840/05 UDI-DI: 04026575359240 Serial/Lot Numbers: 250513/2083, 250513/2085, 250513/2086, 250513/2089, 250513/2090, 250513/2092, 250513/2093, 250513/2097, 250513/2100, 250513/2102, 250513/2104, 250513/2107, 250513/2108, 251013/3245, 251013/3247, 251013/3250, 251013/3251, 251013/3252 Quantity: 44 units Recall Date: 2026-01-12 Status: Active Countries Distributed: Worldwide; US (NJ), Belarus, Canada, Switzerland, Colombia, Germany, Spain, United Kingdom, Hungary, India, Italy, Netherlands, Romania, Saudi Arabia Sold at: Multiple Distributors
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Quantity: 44 units recalled
- Serial/Lot Numbers: 250513/2083 to 251013/3252 (list above)
Browse More Recalls
Safety Guide
Not sure what to do next? Our guide walks you through the process step by step.
Read: What to Do When You Find a Recalled ProductGet Alerts for Health & Personal Care Recalls
Get instant alerts for recalls that affect you. Free forever.