Waldemar Link GmbH & Co. KG is recalling approximately 4,300 SymphoKnee Distal Femoral, Posterior Femoral, L-Shaped Femoral, and Tibial Augments manufactured in Germany. The recall was initiated because some devices were delivered with preassembled femoral augment screws that were missing their threads. This mechanical defect prevents the augment from being properly secured to the implant during knee replacement surgery. The affected products were distributed to surgical centers and hospitals across 17 states between March 2025 and April 2025. No injuries have been reported to date.
If a screw is missing its threads, the augment cannot be securely attached to the femoral or tibial component during surgery. This may result in surgical delays while a functional replacement is found, or if undetected during implantation, it could lead to improper fixation and instability of the knee implant.
Applies to all lots of the LINK SymphoKnee Femoral Augments listed.
Applies to all lots of the LINK SymphoKnee Femoral Augments listed.
Applies to all lots of the LINK SymphoKnee Femoral Augments listed.
Applies to all lots of the LINK SymphoKnee Femoral Augments listed.
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.
Sources: FDA iRES · Raw API Response
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