Aesculap, Inc.: Medical Device Recall in 2015 - (Recall #: Z-2326-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: July 7, 2015

Date Posted: August 12, 2015

Recall Number: Z-2326-2015

Event ID: 71709

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.

Status: Terminated

Product Quantity: 10

Code Information:

product: FW103R, all Lots

Distribution Pattern:

Distributed US (nationwide) and to Canada.

Voluntary or Mandated:

Voluntary: Firm initiated