Recall Z-1666-2013 ยท HXX Screwdriver
SpineFrontier, Inc.
InSpan Inserter, Right Assembly; InSpan Inserter, Left Assembly Product Usage: Inserters are stainless steel instruments that have an inner shaft. The left and right inserters are used in combination with each other to place the implants into the body. Inserters are used to install the InSpan Spinous Plate System for the purpose of achieving supplemental fixation.
| Date | Jul 5, 2013 (initiated May 7, 2013) |
| Status | Terminated |
| Reason | Potential for set screw to be come deformed. |
| Root cause | Device Design |
| Action | Spine Frontier sent an Urgent Advisory Notice letter dated May 30, 2013 to all affected consignees. The letter identified the affected product. problem and actions to be taken. The letter informed consignees that a correction was implemented for InSpan Inserters. Consignees were instructed to remove parts from the field immediately for modification and that replacement Inserters will be shipped upon receipt of completed acknowledgement form and RMA request for part return. For questions call 978-232-3990. |
| Quantity | 61 individual inserter assemblies |
| Distribution | Worldwide Distribution - USA Nationwide: in the states of: FL, CO, VA, KS, TX, OH, TN, OK, CA, IL, MO, MN, Wash DC, including PR and the countries of Dominican Republic, Medico, Panama |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.