Recall Z-1448-2022 ยท NKB Thoracolumbosacral Pedicle Screw System
Aesculap Implant Systems LLC
AESCULAP S4 Cervical Cross Connector L 42-58mm, S4C CROSS CONNECTOR VARIABLE 42-58MM, product code SW117T. Used in spinal fusion surgery.
| Date | Sep 8, 2020 |
| Status | Terminated |
| Reason | Insufficient clamping force of the cross connectors in the spinal surgical system which may lead to movement of the connectors on the rods and/or microparticle abrasion. |
| Root cause | Device Design |
| Action | An Urgent Medical Device Removal Notification issued September 08, 2020 sent via USPS certified mail. The notice identifies the affected part numbers S4C CROSS CONNECTOR SW112T, SW113T, SW114T, SW115T, SW116T and SW117T and asks distributors and customers to identify existing inventory, quarantine, and return affected inventory. If further distributed, identify and notify customers. The notice includes an acknowledgement form to be completed and returned to Aesculap Inc. via email at qa-recalls@aesculapusa.com. Questions are to be directed to Lindsay Chromiak, Manager, QA Compliance and Vigila |
| Quantity | 27 |
| Distribution | United States Nationwide distribution in the states of CA, CO, IL, IN, MI, NC, NV, OH, PA, SC, TX & WY. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K062012 | S4 CERVICAL OCCIPITAL PLATE SPINAL SYSTEM Aesculap, Inc., Feb 9, 2007 |