Recall Z-1417-2013 ยท MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Spinal Solutions, LLC
Copperhead IBFD, Large Neutral, 6mm Copperhead IBFD, Large Neutral, 7mm Copperhead IBFD, Large Neutral, 8mm Copperhead IBFD, Large Neutral, 9mm Copperhead IBFD, Large Neutral, 10mm Copperhead IBFD, Large Neutral, 11mm Product Usage: Spinal Solutions distributes a variety of spinal fixation devices in loaner bins or on consignment. The company has decided to provide directions for use and sur
| Date | May 27, 2013 (initiated Feb 20, 2013) |
| Status | Terminated |
| Reason | The recall of the Loaner Bin and Sterilization Trays for implants and instruments was initiated by Spinal Solutions because the directions for use and surgical techniques were not being provided to every physician and for every surgery. |
| Root cause | Labeling design |
| Action | Spinal Solutions sent a recall letter dated March 8, 2013 to all customers who purchased loaner bins and sterilization trays for implants and instruments from Spinal Solutions. The letter identified the affected product, problem identified and actions to be taken. Customers are instructed to call the office at the number (951) 304-9001 if they are requesting paper copies of any of the literature. |
| Quantity | 24 units |
| Distribution | USA Nationwide Distribution in the states of MS: TX, NV, CA, MD, and WI. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K090064 | EMINENT SPINE INTERBODY FUSION SYSTEM Eminent Spine, Apr 9, 2009 |