Patient: What is next after recall of anterior spinal fusion product? Another surgery etc…?Thank You for your time.
Symptoms: Our records indicate that on 6.26/2009 you had an Anterior Spinal Fusion performed by our Dr. Xxx using this product.
It has thus been recalled bringing it to our attention just recently. Please contact our office on Wednesday 8/26 2015 between 10;00 / 12:00 am,
at xxx to speak with our staff Dr. Xxx to discus further.
Acute Surgical Staff
Class 2 Recall
Spinal Invervetebral Disc Space Orthosis see related information Date Posted June 07, 2012 Recall Status1 Terminated on December 24, 2013 Recall Number Z-1784-2012 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. Products are labeled in part: “FuseLOX Lumbar Cage Lumbar Interbody Fusion Device***Description:***Part Number:***Lot Number:***Quantity: 1***Material: PEEK-OPTIMA LT1, Tantalum ASTM F560***Non-Sterile-Single Use Only (See package insert for sterilization parameters and labeling.)***CAUTION: Federal (United States) law restricts these devices to sale by or on the order of a physician.***Manufactured and distributed by: CAPTIVA SPINE***captivaspine.com***967 Alternate A1A #1 Jupiter, FL 33477 Tel: 877-772-5571 Fax: 866-318-3224 Email: [email protected]***” FPL – F is FuseLOX, P is Plif, C is Lorditic Products subject to recall: FuseLOX Lumbar Lorditic: Lorditic – 7mm x 25mm Part Number: FPL2507 Lot Number 07110010. Lorditic – 8mm x 25mm Part Number FPL2508 Lot Number 07110011. Lorditic – 9mm x 25mm Part Number: FPL2509 Lot Number 07110012. Lorditic – 10mm x 25mm Part Number: FPL2510 Lot Number 07110013. Lorditic – 11mm x 25mm Part Number: FPL2511 Lot Number 07110014. Lorditic – 12mm x 25mm Part Number: FPL2512 Lot Number 07110015. Lorditic – 13mm x 25mm Part Number FPL2513 Lot Number 07110016. Products are packaged individually and shipped as replacement parts to be placed in the FuseLOX Lumbar Caddy which is placed in the FuseLox Lumbar Sterilization tray. The sterilization tray is distributed on consignment. 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: 07110010 thru 07110016.
Manufacturer Captiva Spine, Inc
967 Alternate A1A
Jupiter, Florida 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 CHANGE CONTROL (GMP – GOOD MANUFACTURING PRACTICE): 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 56 units Distribution USA (nationwide) including FL,TX, UT, and NJ. Total Product Life Cycle TPLC Device Report
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.