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Aesculap, Inc. recalls Flexible Screw Driver SJ706R; Non Sterile; B Braun; Aesculap; Aesculap AG These instruments are intended fo
Recalled December 30, 2015 · FDA recall Z-0422-2016 · 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
37
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
Flexible Screw Driver SJ706R; Non Sterile; B Braun; Aesculap; Aesculap AG These instruments are intended for use during the implantations of the A-Space SIBD and Arcadius XP L systems.
Manufacturer(s)
Aesculap, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →