FDA-Device2015-12-30Class II
Flexible Drill; SJ723R; 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.
Aesculap, Inc.
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.
Sold states
Worldwide Distribution: US (nationwide) and country of: Canada.
Affected count
13
Manufactured in
3773 Corporate Pkwy, N/A, Center Valley, PA, United States
Products
Flexible Drill; SJ723R; 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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0424-2016Don't want to check this manually?
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