FDAFDA · Food and drugs·Recall number Z-1934-2012
S4 Cervical (S4C) Revision Instruments (FW099R and FW101R). The S4C Revision Instruments assist in the removal of an occipital cervical screw during revision surgery.
Published July 11, 2012 · Recall initiated: March 7, 2012
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Aesculap Implant Systems, LLC has initiated a voluntary removal of the S4 Cervical (S4C) Occiput Revision Instrument that is part of the S4C Occipital Instrument Set. The instruments may not thread into the screw properly during a revision surgery due to tolerance issues between the two instruments.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Aesculap Implant Systems LLC
- Distributor
- Nationwide distribution, including the states of CA, CO, IL, LA, NV, OH, and TX .
- Lot
- All distributed lot numbers and serial numbers
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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