Recall Z-0424-2016— Aesculap, Inc.
Class II · Terminated
Class II FDA medical device recall by Aesculap, Inc., initiated 2015-11-10, terminated 2016-09-08. FDA's recall record names no specific 510(k) clearance for this event. Product: 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.. 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..
- Recalling firm
- Aesculap, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2015-11-10
- Terminated
- 2016-09-08
- Firm location
- Center Valley, PA, United States
Product description
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.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.