Class 2 Device Recall Spinal Invervetebral Disc Space Orthosis

• Date Initiated by Firm: April 27, 2012
• Date Posted: June 07, 2012
• Recall Status: Terminated on December 24, 2013
• Recall Number: Z-1785-2012
• 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 Trial product is a reuseable component of the Captiva Spine FuseLOX Lumbar product. It is not generally sold as an individually packaged product. ; Trial 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 T is Trial. ; ; Products subject to recall: FuseLOX Lumbar Trials ; Trial - 7mm x 25mm Part Number: FPT2507 Lot Number 8110001. ; Trial - 8mm x 25mm Part Number FPT2508 Lot Number 8110002. ; Trial - 9mm x 25mm Part Number: FPT2509 Lot Number 8110003.; Trial - 10mm x 25mm Part Number: FPT2510 Lot Number 8110004. ; Trial - 11mm x 25mm Part Number: FPT2511 Lot Number 8110005. ; Trial - 12mm x 25mm Part Number: FPT2512 Lot Number 8110006. ; Trial - 13mm x 25mm Part Number FPT2513 Lot Number 8110007. ; Trial - 14mm x 25mm Part Number FPT2514 Lot Number 8110008. ; ; 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: 8110001 thru 8110008.
• 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: 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: 54 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.