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.
Reported: December 30, 2015 Initiated: November 10, 2015 #Z-0422-2016
Product Description
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.
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.
Details
- Recalling Firm
- Aesculap, Inc.
- Units Affected
- 37
- Distribution
- Worldwide Distribution: US (nationwide) and country of: Canada.
- Location
- Center Valley, PA
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Aesculap, Inc.. Units affected: 37.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 30, 2015. Severity: Moderate. Recall number: Z-0422-2016.
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