S4C Occiput Torque Wrench F/Set Screw; used to tighten the S4 Cervical Spinal System clamping screws with a defined torq
FDA device recall Z-2326-2015 · posted 2015-08-03 · Terminated
Recall details
- Recalling firm
- Aesculap, Inc.
- 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.
- Action taken
- 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.
- Root cause
- Labeling design
- Status
- Terminated
- Product code
- HXC
- Quantity affected
- 10
- Distribution
- Distributed US (nationwide) and to Canada.
- Date initiated
- 2015-07-07
- Date posted
- 2015-08-03
- Date terminated
- 2017-04-17
- Location
- Center Valley, PA
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