Aesculap, Inc.: Medical Device Recall in 2015 - (Recall #: Z-0448-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: November 10, 2015

Date Posted: December 30, 2015

Recall Number: Z-0448-2016

Event ID: 72646

Reason for Recall:

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.

Status: Terminated

Product Quantity: unknown

Code Information:

All Lots

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated