Aesculap, Inc. recalls S4C Occiput Torque Wrench F/Set Screw; used to tighten the S4 Cervical Spinal System clamping screws with a defined tor…

Recall date

July 7, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2326-2015

FDA classification

Class II

Brand / firm

Aesculap, Inc.

Sold / distributed

Distributed US (nationwide) and to Canada.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.