Limacorporate S.p.A is recalling 28 units of its PRIMA 2mm and 4mm Eccentrical Adaptors with Screw because the black laser positioning markers may be missing from the device. These markings are necessary for surgeons to identify the correct position of the adaptor during medical procedures. The recall involves specific sterile units manufactured in Italy and distributed worldwide, including several US states.
Missing positioning markers can lead to incorrect alignment or orientation of the adaptor during surgery. This surgical error could result in poor clinical outcomes for the patient or the need for revision surgery to correct the placement.
19 units affected
9 units affected
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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