S4C Occiput Torque Wrench F/Set Screw recall
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…
Why was S4C Occiput Torque Wrench F/Set Screw 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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
product: FW103R, all Lots
- 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…
- Recalling firm
- Aesculap, Inc.
- Quantity
- 10
- Distribution
- Distributed US (nationwide) and to Canada.
- Recall date
- August 12, 2015
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)