Waldemar Link GmbH & Co. KG is recalling 6 units of the Link OptiStem Rasp Handle, which is a tool used by surgeons to prepare the knee bone for an implant during total knee replacement procedures. The recall was initiated because a crack in the weld of the handle can cause the tool's frontal sleeve to break while it is being used or removed from the patient. If the tool fractures, the surgeon would need to use a clamp to extract the broken piece, which leads to longer surgery times or the need to change the surgical procedure entirely.
A fracture of the tool during surgery can cause delays in the procedure and may require additional surgical maneuvers to remove broken components, potentially increasing the duration of anesthesia and the complexity of the operation.
Manufacturer consultation and further instructions
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.
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Sources: FDA iRES · Raw API Response
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