Enforcement Report - Week of September 19, 2012
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Product Detail
| Product Description | 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. |
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| Recall Number | Z-2333-2012 |
| Classification | Class II |
| Code Info | All distributed lots and serial numbers |
| Product Distributed Qty | 5 |
| Reason For Recall | 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. |
Event Detail
| Event Id | 62842 |
|---|---|
| Product Type | Devices |
| Status | Ongoing |
| Recalling Firm | Aesculap Implant Systems LLC |
| City | Center Valley |
| State | PA | Country | US |
| Voluntary / Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 2012-07-25 |
| Initial Firm Notification of Consignee or Public | Telephone |
| Distribution Pattern | Nationwide Distribution-including the states of IL, MN, NV, OK, and TX. |
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