Z-1786-2012

Accessories for the Captiva Spine FuseLOX Lumbar Cage. The FuseLOX Lumbar Inserter product is a reuseable...

Name: Z-1786-2012 Accessories for the Captiva Spine FuseLOX Lumbar Cage. The FuseLOX Lumbar Inserter product is a reuseable...
Creator: Captiva Spine, Inc
Published: 2012-04-27
License: https://open.fda.gov/license/

CAPTIVA SPINE, Inc. / initiated 2012-04-27 / Terminated / root cause: design

FDA source

Captiva Spine, Inc began a recall of Accessories for the Captiva Spine FuseLOX Lumbar Cage. The FuseLOX Lumbar Inserter product is a reuseable component of the Captiva Spine FuseLOX Lumbar... on 2012-04-27. The reason FDA records is "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...". 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-1786-2012
Status: Terminated
Initiated: 2012-04-27
Posted: 2012-06-07
Terminated: 2013-12-24
Recalling firm: CAPTIVA SPINE, Inc.
Product: Accessories for the Captiva Spine FuseLOX Lumbar Cage. The FuseLOX Lumbar Inserter product is a reuseable component of the Captiva Spine FuseLOX Lumbar product. It is not generally sold as an individually packaged product. Inserter products are shipped as a component of the FuseLOX Lumbar Caddy which is placed in the FuseLox Lumbar Sterilization tray. The sterilization tray is distributed on consignment. FPT - F is FuseLOX, P is Plif, and I is Inserter. Products subject to recall: FuseLOX Lumbar Inserter Inserter - Part Number: FPT0200 Lot Number 6110100. Quantity distributed (8) is found in table on page 5 of 6. The FuseLOX Lumbar Cage implant is an intervertebral body fusion device indicated for intervertebral body fusion at one level or two contiguous levels in the lumbar spine from L2 to S1 in patients with degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. The FuseLOX Lumbar Cage Implant is designed for use with autograft to facilitate fusion and is intended for use with supplemental fixation systems cleared for use in the lumbar spine.
Product code: MAX Intervertebral Fusion Device With Bone Graft, Lumbar
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.
Root cause tag: design
FDA root cause: Finished device change control
Action: 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.
Quantity in commerce: 8 units
Distribution: USA (nationwide) including FL,TX, UT, and NJ.
Product codes and lots: Lot Number: 6110100.

Product code MAX

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)