FDA (Devices) recall action 80312
The FDA (Devices) publishes a recall like this one as 5 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 5 pages.
Use of the impacted product may cause a superficial infection requiring PO antibiotics and wound care or deep infection requiring IV antibiotics and device removal.
The agency’s own wording, quoted from the enforcement report.
NewDeal SA is recalling specific UNI-CP medical devices because their use may cause superficial or deep infections requiring antibiotic treatment or device removal.
NewDeal SA is recalling TIBIAXYS devices because use may cause superficial or deep infections requiring antibiotic treatment or device removal.
NewDeal SA is recalling specific ADVANSYS MLP/DLP models because their use may cause superficial or deep infections requiring medical treatment.
NewDeal SA is recalling Large QWIX medical devices because their use may cause superficial or deep infections requiring antibiotic treatment or device removal.
NewDeal SA is recalling ADVANSYS TTC medical devices because they may cause superficial or deep infections requiring antibiotic treatment or device removal.