FDA (Devices) recall action 85296
The FDA (Devices) publishes a recall like this one as 2 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 2 pages.
Space between the device and the packaging permits excessive movement which could potentially lead to the displacement of the anchors tip protector allowing the tip of the anchor to create a sterile breach.
Space between the device and the packaging permits excessive movement which could potentially lead to the displacement of the anchor s tip protector allowing the tip of the anchor to create a sterile breach.
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
Smith & Nephew is recalling 125,196 Footprint Ultra PK Suture Anchors because packaging movement may displace the tip protector, creating a sterile breach.
Smith & Nephew is recalling FOOTPRINT Ultra PK Suture Anchors because excessive movement in packaging could displace the tip protector, potentially causing a sterile breach.