Recall Z-1479-2008 ยท NKB Thoracolumbosacral Pedicle Screw System
Abbott Spine
Sequoia Spinal System Surgical Kits; Pedicle screw spinal system; Non-sterile (kits intended to be sterilized prior to use); Rx Only; The Sequoia Spinal System is designed to aid in the surgical correction of several types of spinal conditions. The product is a system of smaller devices used to provide stabilization during the development of a solid fusion mass.
| Date | Jul 23, 2008 (initiated Feb 13, 2008) |
| Status | Terminated |
| Reason | Screw Head Dissociation: The polyaxial screw head may dissociate from screw shaft during surgery. Also, the polyaxial screw driver is experiencing difficulty (broken/bent driver shafts, difficulty attaching screws to the driver and jamming of the collet.) |
| Root cause | Device Design |
| Action | The recalling firm notified sales reps regarding the recall by phone on 02/13/08. The sales reps were instructed to discontinue kit use in surgeries and to return inventory. Surgeons who had used the Sequoia System in surgery were notified of the recall via letter on 02/20/08. Surgeons were asked to monitor for post-operative dissociation in implanted patients and to notify Abbott Spine sales reps if any incidences occur. |
| Quantity | 38 surgical kits. |
| Distribution | Nationwide Distribution including states of AR, AZ, CA, CT, CO, FL, IL, MD, MI, MN, NC, OH, OK, OR, PA, TX, VA and WI. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K072672 | SEQUOIA SPINAL SYSTEM, MODEL 3300 SERIES Abbott Spine, Inc., Nov 28, 2007 |