Aesculap, Inc. recalls Tray Set containing multiple instruments and may contain the flexible bone awl, flexible drill and/or flexible screw dr…

Recall date

November 10, 2015

Source

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

Recall number

Z-0448-2016

FDA classification

Class II

Brand / firm

Aesculap, Inc.

Sold / distributed

Worldwide Distribution: US (nationwide) and country of: Canada.

Why it was recalled

The flexible shaft of the instruments may break during orthopedic spinal surgery. There is a risk of a delay in surgery or that a fragment from the shaft could be left in a patient.

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

What was recalled

Tray Set containing multiple instruments and may contain the flexible bone awl, flexible drill and/or flexible screw driver in varying amounts depending on order. Tray set is not sealed. These instruments are intended for use during the implantations of the A-Space SIBD and Arcadius XP L systems. Tray catalog number is: Tray designated as ST0485-037.