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U.S. Department of Health and Human Services

Class 2 Device Recall Spinal Invervetebral Disc Space Orthosis

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  Class 2 Device Recall Spinal Invervetebral Disc Space Orthosis see related information
Date Initiated by Firm April 27, 2012
Date Posted June 07, 2012
Recall Status1 Terminated 3 on December 24, 2013
Recall Number Z-1786-2012
Recall Event ID 61925
Product Classification Intervertebral fusion device with bone graft, lumbar - Product Code MAX
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.
Code Information Lot Number: 6110100.
Recalling Firm/
Manufacturer		 Captiva Spine, Inc
967 Alternate A1A
Suite1
Jupiter FL 33477
For Additional Information Contact Tamala J. Wampler
561-277-9480
Manufacturer 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.
FDA Determined
Cause 2		 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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