Recall Z-2333-2012 ยท NKB Thoracolumbosacral Pedicle Screw System
Aesculap Implant Systems LLC
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 foll
| Date | Sep 7, 2012 (initiated Jul 25, 2012) |
| Status | Terminated |
| 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. |
| Root cause | Nonconforming Material/Component |
| Action | Aesculap sent an "IMPORTANT PRODUCT REMOVAL NOTIFICATION" letter dated July 25, 2012 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. A Distribution Inventory Sheet was attached for customers to complete and return with the affected product. Contact the firm at (610) 984-9275 for questions regarding this recall. |
| Quantity | 5 |
| Distribution | Nationwide Distribution-including the states of IL, MN, NV, OK, and TX. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K100623 | AESCULAP IMPLANT SYSTEMS S4 SPINAL SYSTEM Aesculap Implant Systems, Jun 9, 2010 |