Z-2326-2015Class II

S4C Occiput Torque Wrench F/Set Screw; used to tighten the S4 Cervical Spinal System clamping screws with a...

Name: Z-2326-2015 S4C Occiput Torque Wrench F/Set Screw; used to tighten the S4 Cervical Spinal System clamping screws with a...
Creator: Aesculap, Inc.
Published: 2015-07-07
License: https://open.fda.gov/license/

Aesculap Inc / initiated 2015-07-07 / Terminated / root cause: labeling and UDI

FDA source

Aesculap, Inc. began a recall of 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... on 2015-07-07. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2326-2015
Classification: Class II
Status: Terminated
Initiated: 2015-07-07
Posted: 2015-08-03
Terminated: 2017-04-17
Recalling firm: Aesculap Inc
Product: 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 code: HXC Wrench
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.
Root cause tag: labeling and UDI
FDA root cause: Labeling design
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.
Quantity in commerce: 10
Distribution: Distributed US (nationwide) and to Canada.
Product codes and lots: product: FW103R, all Lots

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2326-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2326-2015	Class II	Terminated	Voluntary: Firm initiated	2015-08-12	2015-08-03

Product code HXC

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)