Z-1480-2015Class II

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

Name: Z-1480-2015 Captiva's lumbar intervertebral fusion system Reamers (color code rings on the Reamers)
Creator: Captiva Spine, Inc
Published: 2015-02-25
License: https://open.fda.gov/license/

CAPTIVA SPINE, Inc. / initiated 2015-02-25 / Terminated / root cause: design

FDA source

Captiva Spine, Inc began a recall of Captiva's lumbar intervertebral fusion system Reamers (color code rings on the Reamers) on 2015-02-25. FDA classified it as Class II and gives the reason as "It is possible for the titanium color-coded ring to detach from the Reamers". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1480-2015
Classification: Class II
Status: Terminated
Initiated: 2015-02-25
Posted: 2015-04-21
Terminated: 2015-06-01
Recalling firm: CAPTIVA SPINE, Inc.
Product: Captiva's lumbar intervertebral fusion system Reamers (color code rings on the Reamers).
Product code: LXH Orthopedic Manual Surgical Instrument
Reason for recall: It is possible for the titanium color-coded ring to detach from the Reamers.
Root cause tag: design
FDA 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 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.
Quantity in commerce: 233 devices
Distribution: GA, IN, FL, UT, AZ, CA, and NY
Product codes and lots: Part #: PI-0507, Lot #s:1308811A, 1457704A; Part #: PI-0508, Lot #s: 1308812A, 1457705A; Part #: PI-0509, Lot #s: 1038813A, 1457706A; Part #: PI-0510, Lot #s: 1308814A, 1457707A; Part #: PI-0511, Lot #s: 1308815A, 1457708A; Part #: PI-0512, Lot #s: 1308816A, 1457709A; Part #: PI-0513, Lot #s: 1308817A, 1457710A; Part #: PI-0514, Lot #s: 1308818A, 1457711A; Part #: PI-0507-S, Lot #: 2130005; Part #: PI-0508-S, Lot #: 2130006; Part #: PI-0509-S, Lot #: 2130007; Part #: PI-0510-S, Lot #: 2130008; Part #: PI-0511-S, Lot #: 2130009; Part #: PI-0512-S, Lot #: 2130010; Part #: PI-0513-S, Lot #:2130011; Part #: PI-0514-S, Lot #: 2130012

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1480-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1480-2015	Class II	Terminated	Voluntary: Firm initiated	2015-04-29	2015-04-21

Product code LXH

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)