Recall Z-2823-2015 ยท OLO Orthopedic Stereotaxic Instrument
Medtronic Navigation, Inc.
P/N: 9735023, DRIVER 9735023 SOLERA 5.5/6.0 MAS; P/N: 9735024, DRIVER 9735024 SOLERA 5.5/6.0 MAS CAN; P/N: 9735025, DRIVER 9735025 SOLERA 5.5/6.0 RMAS; P/N: 9735026, DRIVER 9735026 SOLERA 5.5/6.0 RMAS CAN; P/N: 9735027,DRIVER 9735027 SOLERA 5.5/6.0 FAS/SAS. The Medtronic Navigated Solera Screwdrivers are reusable devices that are designed for use in spine surgery to assist in the placement of scr
| Date | Sep 30, 2015 (initiated Sep 14, 2015) |
| Status | Terminated |
| Reason | Specific use conditions can increase the possibility of a screwdriver tip deforming or breaking during surgery. |
| Root cause | Labeling design |
| Action | Medtronic sent an Urgent Medical Device Correction Notification letter dated September 14, 2015, to all affected consignees via FedEx. Revised Instructions for Use were provided to add additional warnings related to the careful inspection of the instruments and the importance of knowledge of operating procedures, patient selection, and product information. Consignees with questions were instructed to to call the local Medtronic Navigation Technical Services Representative or call 1-800-995-9709. |
| Quantity | 2,346 |
| Distribution | Worldwide Distribution - US (nationwide) and Internationally to Canada; United Arab Emirates; Australia; Belgium; Switzerland; China; Germany; Denmark; Spain; Finland; France; Great Britain; Greece; India; Israel; Italy; Japan; Netherlands; New Zealand; Poland; Portugal; Sweden; Singapore; Thailand |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K124004 | NAVIGATED CD HORIZON SOLERA SCREWDRIVERS, TAPS, ILIAC TAPS, LEGACY TAPS Medtronic Navigation, Inc., Mar 22, 2013 |