FDA Device recall Z-2326-2015
S4C Occiput Torque Wrench F/Set Screw
- FDA Device
- Class II
- terminated
- Published 2015-08-12
On 2015-08-12 the FDA classified a Class II recall of S4C Occiput Torque Wrench F/Set Screw by Aesculap, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2326-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-07-07 |
| Published | 2015-08-12 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Aesculap |
| Distribution | US |
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.
Reason
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.
Identifiers
| code_info | product: FW103R, all Lots |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2326-2015%22
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