Recall Z-2677-2014 ยท NKB Thoracolumbosacral Pedicle Screw System
Genesys Orthopedics Systems, LLC
Circular Lock Screws, part # G826, lot # 11406. The Lock Screws are part of the Genesys Spine TiLock Pedicle Screw System. The TiLock Pedicle Screw System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of thoracic, lumbar, and sacral sp
| Date | Sep 22, 2014 (initiated Apr 2, 2014) |
| Status | Terminated |
| Reason | The recall is being initiated because MK Precision (the Circular Lock Screw supplier) notified Genesys Spine that a portion (less than 20%) of the Circular Lock Screws in lot 11406 were manufactured using Stainless Steel in the center Post instead of the specified titanium alloy. |
| Root cause | Nonconforming Material/Component |
| Action | Genesys Spine sent an Urgent Medical Device Recall letter dated April 2, 2014, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to immediately examine their inventory and quarantine any affected product. Customers were instructed to notify their customers (end users) of the recall and request that they return any affected product to Genesys Spine by completing the attached Recall Tracking Form to Genesys Spine, 1250 South Capital of Texas Hwy, Building Three, Suite 600, Austin, Texas 78746. Cus |
| Quantity | 642 |
| Distribution | Nationwide Distribution including NV, CA, NY, MO, TX, FL, NJ, GA, TN. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K100757 | TILOCK PEDICLE SCREW SYSTEM Genesys Spine, Jul 1, 2010 |