Recall Z-0909-2015 ยท NKB Thoracolumbosacral Pedicle Screw System
Ebi, Llc
Cypher MIS Screw System-The system includes screws, various types and sizes of rods, and set screws. Various instruments are also available for use by the surgeon to facilitate implantation of the device. Non-cervical spinal fixation device intended for immobilization and stabilization as an adjunct to fusion.
| Date | Jan 5, 2015 (initiated Oct 8, 2014) |
| Status | Terminated |
| Reason | Inoperative screw head seat splay and/or fracture as a result of positioning of the rod which is a part of the Cypher MIS Screw System. |
| Root cause | Device Design |
| Action | The firm, EBI LLC/Biomet, sent an "URGENT PRODUCT INFORMATION" letter dated 10/6/2014 via Fed Ex to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to follow the steps outlined in the letter. If you have any questions, please feel free to contact Director of Regulatory Affairs at 303-501-8548. |
| Quantity | 2816 approx.units ( 2688 units US and 128 OUS) |
| Distribution | Worldwide Distribution: US Distribution to states of: AL, CA, CT, IN, LA, NC, NJ TX & WI; and the country of: The Netherlands. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K123549 | POLARIS SPINAL SYSTEM - BALLISTA II PERCUTANEOUS SCREW PLACEMENT SYSTEM Biomet Spine (Aka Ebi, LLC), Feb 25, 2013 |