Synthes (USA) Products LLC recalls Synthes Application Instrument for Sternal ZIPFIX; indications for use include primary or secondary closure/repair of t…

Recall date

July 22, 2015

Source

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

Recall number

Z-2475-2015

FDA classification

Class II

Brand / firm

Synthes (USA) Products LLC

Sold / distributed

Nationwide and internationally to Canada.

Why it was recalled

The end cap may loosen and detach making the instrument non-functional. No injuries reported.

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 Application Instrument for Sternal ZIPFIX; indications for use include primary or secondary closure/repair of the sternum following sternotomy or fracture of the sternum to stabilize the sternum and promote fusion