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
- 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 GmbH & Co. KG
- Product type
- Surgical Implant
- Model numbers
- Item Number: 16-2840/02, UDI-DI: 04026575359233, Serial/Lot Number: 250925/0640, 250925/0641, 250925/0642, 250925/0646, 250925/0650, 250925/0652 +12 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 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
The SL Connection Component is a medical device used in surgical procedures involving implants. It provides essential support and fixation for various types of implants.
Why This Is Dangerous
The defect in the SL Connection Component can cause the bushing to detach from the screw shaft due to a longitudinal fracture. This may lead to serious complications during implantation.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
Patients and healthcare providers face immediate risk if the product is used, making it critical to cease all use and follow recall protocols.
Practical Guidance
How to identify if yours is affected
- Check the item number 16-2840/02 on your device.
- Examine the serial numbers listed to see if your product is affected.
- Refer to the recall notice for any specific identifiers.
Where to find product info
Serial numbers and item numbers can usually be found on the packaging or the device itself.
What timeline to expect
Expect a timeline of 4-6 weeks for processing any refunds or replacements.
If the manufacturer is unresponsive
- Reach out to your healthcare provider for guidance.
- Contact the FDA for assistance if the manufacturer is unresponsive.
How to prevent similar issues
- Always verify the recall status of medical devices before use.
- Consult healthcare providers about product history and safety.
Documentation advice
Keep all communication regarding the recall, including emails, letters, and any correspondence with the manufacturer.
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Reported Incidents
No injuries or incidents have been reported.
Key Facts
- 49 SL Connection Components recalled
- High risk of bushing detachment
- Sold worldwide including in New Jersey
- Contact manufacturer for instructions
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Safety Guide
Not sure what to do next? Our guide walks you through the process step by step.
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