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Aesculap, Inc. recalls Flexible Bone Awl; SJ607R; NON STERILE; B Braun Aesculap; Aesculap AG: These instruments are intended for use
Recalled December 30, 2015 · FDA recall Z-0423-2016 · 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
41
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 Bone Awl; SJ607R; 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 →