Synthes (USA) Products LLC recalls Synthes Sciatic Nerve Retractor and Sciatic Nerve Retractor Long; Synthes Sciatic Nerve Retractor and Sciatic Nerve Ret…

Recall date

July 29, 2015

Source

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

Recall number

Z-2418-2015

FDA classification

Class II

Brand / firm

Synthes (USA) Products LLC

Sold / distributed

Nationwide and internationally, including Canada

Why it was recalled

Potential for micropores to form, 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

Synthes Sciatic Nerve Retractor and Sciatic Nerve Retractor Long; Synthes Sciatic Nerve Retractor and Sciatic Nerve Retractor Long are system specific instruments to the 3.5 mm Low Profile Pelvic System Retractor Set.