FDA (Devices) recall action 68482
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.
Mislabeled. Packages labeled PFSI-00053, Right Lateral/Left Medial contains PFSI-00054, Right Medial/Left lateral implants. Packages labeled PFSI-00054, Stride Right Medial/Left Lateral contain PFSI-00053, Left Medial/Right Lateral.
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.
Blue Belt Technologies is recalling specific lots of Stride unicondylar knee prosthesis femoral components due to packaging mislabeling that may result in the wrong implant being used.
Blue Belt Technologies is recalling two lots of Stride Femoral Knee Components due to packaging mislabeling that could lead to the implantation of the wrong side or size.