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

Recalled December 30, 2015 · FDA recall Z-0448-2016 · Aesculap

Hazard

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. · FDA Class II

Units

unknown

Sold at

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

Description

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.

Product

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.

Manufacturer(s)

Aesculap, Inc.

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →