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 anchor s 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 anchors 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 FOOTPRINT Ultra PK Suture Anchors because excessive movement in packaging could displace the tip protector, potentially causing a sterile breach.
Smith & Nephew is recalling 125,196 Footprint Ultra PK Suture Anchors because packaging movement may displace the tip protector, creating a sterile breach.