Instructions For Use: "***SmartLOX***Instructions for Use Cervical Plate System***STERILIZATION***The SmartLOX Cervical
FDA device recall Z-1545-2012 · posted 2012-05-14 · Terminated
Recall details
- Recalling firm
- Captiva Spine, Inc
- Reason for recall
- 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.
- Action taken
- 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.
- Root cause
- Labeling False and Misleading
- Status
- Terminated
- Product code
- KWQ
- Quantity affected
- 14 units
- Distribution
- Nationwide Distribution including the states of FL, IN, UT, GA, PA, TX, AL, NC, MI, and MN.
- Date initiated
- 2012-03-22
- Date posted
- 2012-05-14
- Date terminated
- 2013-11-18
- Location
- Jupiter, FL
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| FIXED, VARIABLE & CORPECTOMY CERVICAL PLATE SYSTEM (K073708) | Precision Surgery , Ltd. | 2008-06-03 |