Quick Facts at a Glance
- Recall Date
- July 31, 2025
- Hazard Level
- HIGH
- Brand
- Waldemar Link GmbH & Co. KG
- Category
- Health & Personal Care
- Sold At
- Unknown
- Geographic Scope
- 1 states
- At-Risk Groups
- GENERAL, PREGNANT, ELDERLY
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
- Orthopedic Tibial Component
- Model numbers
- 880-100/50, 210125/2259, 210125/2262, 210125/2268, 210125/2260, 210125/2264, 210125/2270, 210125/2272 +1 more
- Sizes
- Sz. 5
- Sold at
- Unknown
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
July 31, 2025
Reported by FDA DEVICE
September 17, 2025
RecallRadar source check
April 18, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
Some modular LinkSymphoKnee TiNbN Tibial Components were manufactured with two uncoated security screws, which is incorrect.
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: E-Mail
About This Product
This is a modular knee tibial component used in knee replacement procedures. It is part of the LinkSymphoKnee system and engineered for modularity in total knee arthroplasty.
Why This Is Dangerous
Two uncoated security screws could compromise fixation, potentially impacting implant stability and function.
Industry Context
This recall is not described as part of a broader industry pattern in the provided data.
Real-World Impact
High risk to implant stability may necessitate urgent clinical assessment and potential revision surgery.
Practical Guidance
How to identify if yours is affected
- Verify REF 880-100/50 on the tibial component labeling
- Consult surgeon to confirm model and lot
Where to find product info
UDI-DI on packaging and device labeling; REF number on product and accompanying documentation
What timeline to expect
Remedies and replacements are at the manufacturer’s discretion; no generic timeline provided
If the manufacturer is unresponsive
- File a complaint with the FDA If necessary
- Request escalation with the manufacturer through formal channels
- Consider seeking a second medical opinion if symptoms arise
How to prevent similar issues
- Verify device integrity during follow-up visits
- Review implant components for modular screws during revision planning
- Maintain updated medical records and recall communications
- Ensure hospital procurement uses correct, coated screws per specification
Documentation advice
Document all recall communications, surgical notes, and any adverse events; retain packaging and labeling for audit
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Product Details
Brand: Waldemar Link GmbH & Co. KG. Product: LinkSymphoKnee System, Tibial Component, Modular, Symmetric, Sz. 5, CoCrMo/TiNbN, cemented, Fixed. REF Number: 880-100/50. Quantity: 8 units. Distribution: Worldwide; US (CO, IN, NJ, TX); Germany; Italy. UDI-DI: 04026575251278. Models: 210125/2259, 210125/2262, 210125/2268, 210125/2260, 210125/2264, 210125/2270, 210125/2272, 210125/2273.
Reported Incidents
No injuries or incidents have been reported in the provided data.
Key Facts
- Two uncoated security screws
- Broad distribution: US (CO, IN, NJ, TX), Germany, Italy
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