Reported Aug 12, 2015 · Terminated
S4C Occiput Torque Wrench F/Set Screw; used to tighten the S4 Cervical Spinal System clamping screws with a defined…
Aesculap, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Aesculap, Inc. · 3773 Corporate Pkwy · Center Valley, PA · 18034-8217
Is this the product you have?
- 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.
- Lot codes and dates
- productFW103R, all Lots
- Amount recalled
- 10
Where it was sold
- Nationwide
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
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