FDA (Devices) recall action 95154
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.
Smith & Nephew, Inc., has initiated a field action to voluntarily remove two batches of K-Wires due to a packaging error. A complaint was received indicating that a package contained K-WIRE .062X9 2PT DM wires instead of K-WIRE .045X9 2PT DM as described on the product label.
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 issued a voluntary recall of K-Wire bone fixation fasteners due to a packaging error where packages contained the wrong wire diameter than labeled.
Smith & Nephew is recalling K-Wire surgical devices due to a packaging error that resulted in wrong-sized wires being distributed. Healthcare providers may have received incorrectly sized bone fixation fasteners affecting approximately 73 units.