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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.

FDA Recall Z-2326-2015 · Posted 2015-08-03

Recalling FirmAesculap, Inc.
Recall StatusTerminated
Product CodeHXC
Date Initiated2015-07-07
Date Terminated2017-04-17
Product Quantity10

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.

Firm 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.

Root Cause

Labeling design

Distribution Pattern

Distributed US (nationwide) and to Canada.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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