FDA-Device2015-08-12Class II
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.
Aesculap, Inc.
Hazard
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.
Sold states
Distributed US (nationwide) and to Canada.
Affected count
10
Manufactured in
3773 Corporate Pkwy, N/A, Center Valley, PA, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2326-2015Don't want to check this manually?
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