Recall Z-1545-2012 ยท KWQ Appliance, Fixation, Spinal Intervertebral Body
Captiva Spine, Inc
Instructions For Use: "***SmartLOX***Instructions for Use Cervical Plate System***STERILIZATION***The SmartLOX Cervical Plate System components are supplied clean and not sterile. All implants and instruments should be cleaned and sterilized prior to surgery. AORN recommended practices for in hospital sterilization should be followed. Sterilization testing of components has shown the following
| Date | May 14, 2012 (initiated Mar 22, 2012) |
| Status | Terminated |
| Reason | Captiva Spine has initiated a correction of the SmartLOX Instructions for Use (IFU) for SmartLOX Cervical Plate System. The pre vacuum sterilization cycle [270 (132 C) for 3 minutes] has not been validated. |
| Root cause | Labeling False and Misleading |
| Action | Captiva Spine sent a "VOLUNTARY CORRECTION NOTIFICATION" letter dated March 23, 2012 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. The letter provides steps for the correction and a verification form for customers to complete. Customers should contact the firm at 877-772-5571 for questions concerning this notice. |
| Quantity | 14 units |
| Distribution | Nationwide Distribution including the states of FL, IN, UT, GA, PA, TX, AL, NC, 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 |