FDAFDA · Food and drugs·Recall number Z-0422-2016
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.
Published December 30, 2015 · Recall initiated: November 10, 2015
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Aesculap, Inc.
- Distributor
- Worldwide Distribution: US (nationwide) and country of: Canada.
- Lot
- All Lots
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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