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.
- Company
- Aesculap Inc
- Recall Initiated
- July 7, 2015
- Posted
- August 3, 2015
- Terminated
- April 17, 2017
- Recall Number
- Z-2326-2015
- Quantity
- 10
- Firm Location
- Center Valley, PA
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.
Distribution
Distributed US (nationwide) and to Canada.
Lot / Code Info
product: FW103R, all Lots
Root Cause
Labeling design
Action Taken
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.
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