Class 2 Device Recall S4C Occiput Torque Wrench F/Set Screw

• Date Initiated by Firm: July 07, 2015
• Date Posted: August 03, 2015
• Recall Status: Terminated on April 17, 2017
• Recall Number: Z-2326-2015
• Recall Event ID: 71709
• Product Classification: Wrench - Product Code HXC
• Product: S4C Occiput Torque Wrench F/Set Screw; used to tighten the S4 Cervical Spinal System clamping screws with a defined torque 2.8 Nm for tightening the clamping screw in the screw head/hook head/occipital plate/transverse connector and other connectors.
• Code Information: product: FW103R, all Lots
• Recalling Firm/ Manufacturer: Aesculap, Inc.; 3773 Corporate Pkwy; Center Valley PA 18034-8217
• For Additional Information Contact: Customer Support; 800-258-1946 Ext. 5067
• Manufacturer Reason for Recall: A FW103R torque wrench that was improperly reassembled after reprocessing caused a screw to break during implantation due to too much torque. The firm did not include instructions for reassembly after reprocessing.
• FDA Determined Cause: Labeling design
• Action: Aesculap sent Field Safety Notification Letters, dated July 7, 2015, to end users, sales consultants, and distributors to advise them about the issue. Enhancements to the instructions for use were made available on the firm's website.
• Quantity in Commerce: 10
• Distribution: Distributed US (nationwide) and to Canada.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.