Synthes (USA) Products LLC recalls Retractor f/Sciatic Nerve; Part number: 03.100.013; UDI: 10886982070623

Recall date

April 2, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1758-2018

FDA classification

Class II

Brand / firm

Synthes (USA) Products LLC

Sold / distributed

US Nationwide and Canada

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Retractor f/Sciatic Nerve; Part number: 03.100.013; UDI: 10886982070623