FDA Recall
Terminated
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.
Recall: Z-2326-2015
·
Initiated July 7, 2015
Recall
- Recall Number
- Z-2326-2015
- Event Number
- 71709
- Firm
- Aesculap, Inc.
- FEI Number
- 2916714
- Product Code
- HXC
- Status
- Terminated
- Root Cause
- Labeling design
- Initiated
- July 7, 2015
- Posted
- August 3, 2015
- Terminated
- April 17, 2017
- Address
- 3773 Corporate Pkwy, Center Valley, PA, 18034-8217
Description
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.
Reason
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.
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.
Distribution
Distributed US (nationwide) and to Canada.
Quantity
10