Recall Z-1648-2012 ยท KWQ Appliance, Fixation, Spinal Intervertebral Body
Captiva Spine, Inc
Accessories for the Captiva Spine SmartLOX Cervical Plate System. Products are labeled in part: "***Part Number CP40012***12mm Drill Bit***Lot Number 89427-2 R***" "***Part Number CP40014***14mm Drill Bit***Lot Number 89427-3-R***" The Captiva Spine SmartLOX Cervical Plate System is intended for the anterior screw fixation of the cervical spine. These implants have been designed
| Date | May 23, 2012 (initiated Nov 22, 2011) |
| Status | Terminated |
| Reason | Captiva Spine is recalling the SmartLOX Cervical Plate components 12 & 14 mm Drill Bits, Single Barrel Variable Drill Guides, and Double Barrel Fixed Drill Guides. The components are part of the instrumentation kit used to complete an anterior screw fixation of the cervical spine. There is a potential risk for the drills to not properly fit through the drill guides due to an overlap in the dime |
| Root cause | Nonconforming Material/Component |
| Action | Captiva Spine notified customers of the recall by letter on November 23, 2011, and advised that the affected products would be replaced. Customers were asked to return the drill guides and unused drills with the provided return labels. For questions customers should call 877-772-5571. For questions regarding this recall call 561-277-9480. |
| Quantity | 212 units |
| Distribution | Nationwide Distribution including TX, IN, UT, AZ, GA, CA, AL, MI, and MN. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K073708 | FIXED, VARIABLE & CORPECTOMY CERVICAL PLATE SYSTEM Precision Surgery , Ltd., Jun 3, 2008 |