Recall Z-1480-2015 ยท LXH Orthopedic Manual Surgical Instrument
Captiva Spine, Inc
Captiva's lumbar intervertebral fusion system Reamers (color code rings on the Reamers).
| Date | Apr 21, 2015 (initiated Feb 25, 2015) |
| Status | Terminated |
| Reason | It is possible for the titanium color-coded ring to detach from the Reamers. |
| Root cause | Device Design |
| Action | On 02/26/2015 the firm sent a Voluntary Correction Notification to its consignees via FedEx. Within that notification the firm asks to please check with your product representative and Central Supply Departments to determine if you have any of the products listed on the notificaiton. If any product is located please call 877-772-5571 from 8:30am (Eastern Time) to receive instructions as to how to remove the color-coded ring OR please follow the enclosed steps for the correction in their entirety. They contain information about returning the removed rings. Enclosed is Form 30.4 Product Trac |
| Quantity | 233 devices |
| Distribution | GA, IN, FL, UT, AZ, CA, and NY |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.