Medicrea International is recalling 44 units of its IB3D Universal Implant Inserters and IB3D PL Instrument Sets used in orthopedic procedures. The recall was initiated because the tool's rotation handle can untread from the shaft, which prevents the surgeon from properly rotating the implant during surgery. If you use these instruments, please stop using them immediately and contact the manufacturer to arrange for a return or replacement.
If the rotation tool handle detaches during a procedure, the clinician will be unable to position the implant correctly, which can lead to surgical delays or improper implant placement. While complaints have been received regarding this defect, no specific injuries have been reported.
Recall #: Z-1038-2026
Recall #: Z-1039-2026
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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