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Terminated

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.

FDA Recall Z-1786-2012 · Posted 2012-06-07

Recalling FirmCaptiva Spine, Inc
Recall StatusTerminated
Product CodeMAX
Date Initiated2012-04-27
Date Terminated2013-12-24
Product Quantity8 units

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.

Firm 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.

Root Cause

Finished device change control

Distribution Pattern

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

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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