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.
Reported: August 12, 2015 Initiated: July 7, 2015 #Z-2326-2015
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.
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.
Details
- Recalling Firm
- Aesculap, Inc.
- Units Affected
- 10
- Distribution
- Distributed US (nationwide) and to Canada.
- Location
- Center Valley, PA
Frequently Asked Questions
What product 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.. Recalled by Aesculap, Inc.. Units affected: 10.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 12, 2015. Severity: Moderate. Recall number: Z-2326-2015.
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