Captiva Spine, Inc: Medical Device Recall in 2015 - (Recall #: Z-1480-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: February 25, 2015

Date Posted: April 29, 2015

Recall Number: Z-1480-2015

Event ID: 70710

Reason for Recall:

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

Status: Terminated

Product Quantity: 233 devices

Code Information:

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

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated