FDA (Devices) recall action 98431
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.
The surgical technique for the Embrace Shoulder Instruments - Drill Tower has mixed-up article numbers in the overview of the instruments. However, the individual surgical steps described in the surgical technique are correct.
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.
Waldemar Link is recalling the Embrace Drill Tower, Standard/Lateral, because the surgical technique document has mixed-up article numbers in the instrument overview, although the surgical steps are correct.
Waldemar Link is recalling the Embrace Drill Tower because the surgical technique document has mixed-up article numbers in the instrument overview, although the individual surgical steps are correct.