Augmedics Ltd. is recalling 85 units of the Augmedics Perc Pin Adaptor (Model AMCH07200), which is used as a component of the xvision Spine (XVS) image-guided navigation system. The adaptor's tightening knob was found to be inconvenient for users, and the tightening markings were improperly placed. This system is intended to help surgeons accurately place pedicle screws during spinal surgery.
Improper markings or a difficult tightening mechanism on surgical equipment could lead to user error or placement inaccuracies during spinal procedures. While no injuries or incidents have been reported, these defects could compromise the precision of computer-assisted surgery.
Component of the xvision Spine (XVS) system.
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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