FDA (Devices) recall action 79850
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.
There is a potential for microspores to form on the hollow handle of the Sciatic Nerve Retractor. The pores may increase in size, allowing fluid to enter the hollow handle.
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.
Synthes (USA) Products LLC is recalling 235 Sciatic Nerve Retractors due to a potential for microspores to form on the hollow handle, which could allow fluid entry.
Synthes (USA) Products LLC is recalling 196 Sciatic Nerve Retractors due to a potential for microspores to form on the hollow handle, which could allow fluid entry.