FDA (Devices) recall action 92078
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.
Two lots of Ortholoc 3Di Fusion plates contain incorrect dorsiflexion descriptions laser marked on the parts.
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.
Wright Medical Technology is recalling Stryker ORTHOLOC 3Di Fusion Plate MTP Right surgical implants due to incorrect dorsiflexion descriptions laser marked on 50 units distributed nationwide.
Wright Medical Technology recalls Stryker ORTHOLOC 3Di Fusion Plate MTP Right devices due to incorrect dorsiflexion descriptions laser marked on the parts. 41 units distributed nationwide.