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
- Endo-Model SL Connection Component incl. PE-Plateau
- Model numbers
- 16-2840/07, UDI-DI: 04026575359257, Serial/Lot Numbers: 250925/0480 to 250925/0352
- 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 product is an implant component used in the Endo-Model SL system with a PE-Plateau. It is distributed globally and used by healthcare professionals in surgical settings.
Why This Is Dangerous
A longitudinal fracture can cause the bushing to detach from the screw shaft, potentially affecting implant stability and patient safety.
Industry Context
This recall is not described as part of a broader industry pattern in the provided data.
Real-World Impact
No injuries reported to date. The hazard is high and could necessitate medical intervention if an affected implant is encountered.
Practical Guidance
How to identify if yours is affected
- Check Item Number 16-2840/07 on the device packaging or documentation
- Review Serial/Lot Numbers listed (250925/0480 through 250925/0352)
Where to find product info
Recall notice, device labeling, UDI information, and manufacturer communications
What timeline to expect
The recall timeline for refunds or replacements is not specified. Typical industry timelines range from 4-8 weeks, depending on the provider.
If the manufacturer is unresponsive
- Escalate to the manufacturer with documented records
- If no resolution, contact regulatory authorities (e.g., FDA) and file a consumer safety complaint
- Maintain records of all correspondence and dates of contact
How to prevent similar issues
- Verify UDI and serial numbers before implanting devices
- Use devices from authorized distributors
- Monitor regulatory recall databases for updates to recalls
- Consult manufacturers for recalls before surgical use
Documentation advice
Keep the recall letter, packaging and labeling, model number, UDI, list of serial/lot numbers, photos, and all communications with providers and manufacturers
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Product Details
Item Number: 16-2840/07 UDI-DI: 04026575359257 Serial/Lot Numbers: 250925/0480, 250925/0481, 250925/0482, 250925/0483, 250925/0484, 250925/0486, 250925/0489, 250925/0491, 250925/0492, 250925/0494, 250925/0503, 250925/0504, 250925/0345, 250925/0346, 250925/0349, 250925/0350, 250925/0351, 250925/0352 Quantity: 31 units Sold worldwide; US nationwide distribution in New Jersey; Countries: Belarus, Canada, Switzerland, Colombia, Germany, Spain, United Kingdom, Hungary, India, Italy, Netherlands, Romania, Saudi Arabia Price: Unknown Sold From/To: Unknown
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Serial/Lot numbers listed (18 entries)
- Worldwide distribution including US NJ and 13 named countries
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Safety Guide
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