Device 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.
Z-0423-2016
Product summary
- Firm
- Aesculap, Inc.
- Event
- Event 72646
- Status
- Terminated
- Classification
- Class II
- Quantity
- 41
- Official record key
device-enforcement:Z-0423-2016
Official wording
Reason: 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.
Code information: all lots
Distribution pattern: Worldwide Distribution: US (nationwide) and country of: Canada.
Derived failure modes
-
Unknown
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.