Zimmer Gmbh recalls Zimmer Natural Nail CM Long. Intramedullary Fixation Rod. The Zimmer Natural Nail System is intended for temporary frac…

Recall date

September 3, 2015

Source

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

Recall number

Z-0119-2016

FDA classification

Class II

Brand / firm

Zimmer Gmbh

Sold / distributed

US Nationwide distribution.

Why it was recalled

In about 5% of tested samples, the outer tray was found to be compromised. Risks: A damaged outer tray detected during surgery may cause a delay in surgery to obtain another implant. If a compromised packaging is not detected prior or during a surgery by the user, it may lead to periprosthetic infection. This may result in revision or multi-stage revision to treat the infection.

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

What was recalled

Zimmer Natural Nail CM Long. Intramedullary Fixation Rod. The Zimmer Natural Nail System is intended for temporary fracture fixation and stabilization of the bone.