FDAFDA · Food and drugs·Recall number Z-2333-2012
Aesculap S4 Element 4.5mm Polyaxial Screws (ST240T, ST241T, ST242T, ST243T, ST244T, and ST245T). The S4 Spinal System is intended for anterior/anterolateral and posterior, non-cervical pedicle and non-pedicle fixation. Fixation is limited to skeletally mature patients and is intended to be used as an adjunct to fusion using autograft or allograft. The device is indicated for treatment of the following acute and chronic instabilities or deformities: 1 - degenerative disc disease, 2 - spondylolisthesis, 3 - trauma, 4 - spinal stenosis, 5 - deformities or curvatures, 6 - tumor, 7 - pseudoarthrosis, and 8 - failed previous fusion.
Published September 19, 2012 · Recall initiated: July 25, 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
There is a possibility that the screw channel that holds the rod in place may be out of tolerance. When the depth of the channel is not deep enough, the rod may not be able to provide ample compression on the insert preventing the screw head from locking down to the bone screw.
What to do
Voluntary: Firm initiated · Telephone
Recall details
- Manufacturer
- Aesculap Implant Systems LLC
- Distributor
- Nationwide Distribution-including the states of IL, MN, NV, OK, and TX.
- Lot
- All distributed lots and serial numbers
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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