Accessories for the Captiva Spine FuseLOX Lumbar Cage. The Trial product is a reuseable component of the Captiva Spine F

FDA device recall Z-1785-2012 · posted 2012-06-07 · Terminated

Recall details

Recalling firm

Captiva Spine, Inc

Reason for recall

Captiva Spine, Inc. initiated a recall of FuseLOX Lumbar Implants, Trials, and Inserters after FDA advised the firm that there is inadequate support for implemented design changes to the cleared device Pivotec Lumbar Interbody Fusion Device.

Action taken

Captiva Spine sent a Voluntary Correction Notification letter dated May 4, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to locate and return affected devices. Customers were also instructed to complete and return a Tracking/Verification Form. For questions customers were instructed to call 877-772-5571. For questions regarding this recall call 561-277-9480.

Root cause

Finished device change control

Status

Terminated

Product code

MAX

Quantity affected

54 units

Distribution

USA (nationwide) including FL,TX, UT, and NJ.

Date initiated

2012-04-27

Date posted

2012-06-07

Date terminated

2013-12-24

Location

Jupiter, FL