Recall Z-1783-2012
Captiva Spine, Inc · initiated April 27, 2012
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: info@captivaspine.com***" FPC - F is FuseLOX, P is Plif, C is Convex Products subject to recall: Convex - 7mm x 25mm Part Number: FPC2507 Lot Number 07110002. Convex - 8 mm x 25mm Part Number FPC2508 Lot Number 07110003. Convex - 9mm x 25mm Part Number: FPC2509 Lot Number 07110004. Convex - 10mm x 25mm Part Number: FPC2510 Lot Number 07110005. Convex - 11mm x 25mm Part Number: FPC2511 Lot Number 07110006. Convex - 12mm x 25mm Part Number: FPC2512 Lot Number 07110007. Convex - 13mm x 25mm Part Number FPC2513 Lot Number 07110008. Convex - 14mm x 25mm Part Number FPC2514 Lot Number 07110009. 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.
Codes / lots: Lot Number: 07110002 thru 07110009.
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 taken
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.
Details
- Recall number
- Z-1783-2012
- Initiated
- April 27, 2012
- Posted by FDA
- June 7, 2012
- Terminated
- December 24, 2013
- Product code
- MAX – Intervertebral Fusion Device With Bone Graft, Lumbar
- Quantity
- 136 units
- Distribution
- USA (nationwide) including FL,TX, UT, and NJ.
- Recalling firm
- Captiva Spine, Inc, Jupiter, FL
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1784-2012 | Accessories for the Captiva Spine FuseLOX Lumbar Cage. Products are labeled in part:…Captiva Spine, Inc. initiated a recall of FuseLOX Lumbar Implants, Trials, and Inserters after FDA advised… | 04/27/2012Terminated |
| Z-1785-2012 | Accessories for the Captiva Spine FuseLOX Lumbar Cage. The Trial product is a reuseable…Captiva Spine, Inc. initiated a recall of FuseLOX Lumbar Implants, Trials, and Inserters after FDA advised… | 04/27/2012Terminated |
| Z-1786-2012 | Accessories for the Captiva Spine FuseLOX Lumbar Cage. The FuseLOX Lumbar Inserter…Captiva Spine, Inc. initiated a recall of FuseLOX Lumbar Implants, Trials, and Inserters after FDA advised… | 04/27/2012Terminated |