Device product
Tray Set containing multiple instruments and may contain the flexible bone awl, flexible drill and/or flexible screw driver in varying amounts depending on order. Tray set is not sealed. These instruments are intended for use during the implantations of the A-Space SIBD and Arcadius XP L systems. Tray catalog number is: Tray designated as ST0485-037.
Z-0448-2016
Product summary
- Firm
- Aesculap, Inc.
- Event
- Event 72646
- Status
- Terminated
- Classification
- Class II
- Quantity
- unknown
- Official record key
device-enforcement:Z-0448-2016
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.