FDA (Devices) recall action 86526
The FDA (Devices) publishes a recall like this one as 4 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 4 pages.
Product may be mislabeled.
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.
Merete Medical GmbH is recalling 354 OsteoBridge Intramedullary Diaphysis Segment Fixation nails for the femur because the product may be mislabeled.
Merete Medical GmbH is recalling 144 units of OsteoBridge Intramedullary Diaphysis Segment Fixation nails for the humerus because the product may be mislabeled.
Merete Medical GmbH is recalling 215 OsteoBridge Intramedullary Diaphysis Segment Fixation nails for the tibia because the product may be mislabeled.
Merete Medical GmbH is recalling 306 units of OsteoBridge Intremedullary Knee Arthrodesis nails because the product may be mislabeled.