Recall Z-2326-2015 ยท HXC Wrench
Aesculap, Inc.
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.
| Date | Aug 3, 2015 (initiated Jul 7, 2015) |
| Status | Terminated |
| 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. |
| 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 | 10 |
| Distribution | Distributed US (nationwide) and to Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.