Waldemar Link GmbH & Co. KG recalled eight units of the LinkSymphoKnee Tibial Component on July 31, 2025. The recall stems from a manufacturing error involving uncoated security screws. Patients and healthcare providers should stop using the device immediately.
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
The recalled product is the LinkSymphoKnee Tibial Component, Modular, Symmetric, Size 5, CoCrMo/TiNbN, cemented, Fixed. The REF Number is 880-100/50. These components were distributed in the United States and internationally.
The recall is due to the presence of two uncoated security screws, which poses a high risk to patients. This defect could potentially lead to device failure or complications.
No specific incidents or injuries have been reported related to this recall. However, the high hazard level indicates serious potential risks.
Stop using the device immediately. Follow the recall instructions provided by the manufacturer. Contact Waldemar Link GmbH & Co. KG or your healthcare provider for further instructions.
For more information, contact Waldemar Link GmbH & Co. KG via email. Visit the FDA recall page for updates at https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-2541-2025.
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