Eight modular LinkSymphoKnee TiNbN tibial components are under recall after production with two uncoated security screws. Waldemar Link GmbH & Co. KG disclosed the issue. The devices were distributed worldwide, including CO, IN, NJ and TX in the United States, plus Germany and Italy. Consumers should stop using the device immediately and follow manufacturer instructions.
Some modular LinkSymphoKnee TiNbN Tibial Components were manufactured with two uncoated security screws, which is incorrect.
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
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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.
Two uncoated security screws could compromise fixation, potentially impacting implant stability and function.
This recall is not described as part of a broader industry pattern in the provided data.
High risk to implant stability may necessitate urgent clinical assessment and potential revision surgery.
UDI-DI on packaging and device labeling; REF number on product and accompanying documentation
Remedies and replacements are at the manufacturer’s discretion; no generic timeline provided
Document all recall communications, surgical notes, and any adverse events; retain packaging and labeling for audit
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.
No injuries or incidents have been reported in the provided data.
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