Product Wiki · Recalls · U.S. FDA — Device Enforcement

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

U.S. FDA — Device Enforcement · United States · 2015-07-07 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2326-2015
Date of alert
2015-07-07
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Aesculap, Inc.
Product category
device
Product type
Devices
Reported risk: 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.
Primary source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=1&

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