Elekta Instrument AB has recalled 111 kits (containing 666 needles total) of the Elekta Disposable Biopsy Needle Kit for the Leksell Stereotactic System. The manufacturer discovered that microscopic stainless steel debris may be present inside the biopsy needles. These needles are used by surgeons for the localization, diagnosis, and surgical treatment of brain disorders, including radiosurgery and stereotactic radiation therapy. No injuries or incidents have been reported to date.
The presence of microscopic stainless steel debris inside the biopsy needle could lead to the introduction of foreign metal fragments into a patient's brain during a procedure. This poses a risk of internal tissue damage, inflammation, or other complications if the material is not identified and removed.
Quantity affects 111 kits total (666 needles).
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.
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Sources: FDA iRES · Raw API Response
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