Captiva's lumbar intervertebral fusion system Reamers (color code rings on the Reamers).

FDA device recall Z-1480-2015 · posted 2015-04-21 · Terminated

Recall details

Recalling firm

Captiva Spine, Inc

Reason for recall

It is possible for the titanium color-coded ring to detach from the Reamers.

Action taken

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 Tracking and Verification Form. You must complete and return this form even if you do not have any rings to remove and return. Please contact your Captiva Spine customer service representative if you have any questions regarding this correction, any of our products, or would like assistance with the correction.

Root cause

Device Design

Status

Terminated

Product code

LXH

Quantity affected

233 devices

Distribution

GA, IN, FL, UT, AZ, CA, and NY

Date initiated

2015-02-25

Date posted

2015-04-21

Date terminated

2015-06-01

Location

Jupiter, FL