Recall Z-1784-2012 ยท MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Captiva Spine, Inc
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 d
| Date | Jun 7, 2012 (initiated Apr 27, 2012) |
| Status | Terminated |
| Reason | 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. |
| Root 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 | 56 units |
| Distribution | USA (nationwide) including FL,TX, UT, and NJ. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.