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

Recall date

October 19, 2015

Source

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

Recall number

Z-0276-2016

FDA classification

Class II

Brand / firm

Synthes (USA) Products LLC

Sold / distributed

Distributed in the states of KY, UT, CA, WI, OH, CO, IL, TX, OK, WA, MI, LA, MA, PA and NE.

Why it was recalled

Certain lots of the Application Instrument for Sternal ZIPFIX that were previously recalled on August 19, 2015 and subsequently repaired and returned to customers between August 26, 2015 and September 23, 2015. The screws on the repaired instruments have the potential to break or loosen. DePuy Synthes is requesting the return of the repaired device in exchange for a new device.

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.