Flexible Drill; SJ723R; NON STERILE; B Braun Aesculap; Aesculap AG These instruments ar...

FDA Device Recall #Z-0424-2016 — Class II — November 10, 2015

Recall Summary

Recall Number Z-0424-2016
Classification Class II — Moderate risk
Date Initiated November 10, 2015
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Aesculap, Inc.
Location Center Valley, PA
Product Type Devices
Quantity 13

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.

Distribution Pattern

Worldwide Distribution: US (nationwide) and country of: Canada.

Lot / Code Information

All Lots

Other Recalls from Aesculap, Inc.

Recall # Classification Product Date
Z-1043-2016 Class II Columbus Revision Knee System, EnduRo Knee Syst... Nov 30, 2015
Z-0566-2016 Class II Valve XS Atrium Retractor FC429R 52154756 ... Nov 17, 2015
Z-0423-2016 Class II Flexible Bone Awl; SJ607R; NON STERILE; B B... Nov 10, 2015
Z-0448-2016 Class II Tray Set containing multiple instruments and ma... Nov 10, 2015
Z-0422-2016 Class II Flexible Screw Driver SJ706R; Non Sterile; ... Nov 10, 2015

Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.