FDA Device recall Z-2333-2012
Aesculap S4 Element 4.5mm Polyaxial Screws (ST240T, ST241T, ST242T, ST243T, ST244T, and ST245T). The S4 Spinal System is intended for anter…
- FDA Device
- Class II
- terminated
- Published 2012-09-19
On 2012-09-19 the FDA classified a Class II recall of Aesculap S4 Element 4.5mm Polyaxial Screws (ST240T, ST241T, ST242T, ST243T, ST244T, and ST245T). The S4 Spinal System is intended for anter… by Aesculap Implant Systems, citing 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 pro….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2333-2012 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2012-07-25 |
| Published | 2012-09-19 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Aesculap Implant Systems |
| Distribution | US |
Product
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.
Reason
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.
Identifiers
| code_info | All distributed lots and serial numbers |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2333-2012%22
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