Recall Z-1412-2013 ยท MNI Orthosis, Spinal Pedicle Fixation
Spinal Solutions, LLC
40 mm Rod, Item #BG1640 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 surgical techniques electronically on the companys website. The company has created a label intended to inform the user of the existence of the websites and the information it contains. Indications for
| 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 | 63 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
| K110633 | LANCER PEDICLE SCREW SYSTEM Spinal Solutions, LLC, Dec 15, 2011 |