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 screws during the surgery, using a Medtronic computer-assisted surgery system.
This recall has been terminated (originally issued September 30, 2015).
- Company
- Medtronic Navigation, Inc.
- Recall Initiated
- September 14, 2015
- Posted
- September 30, 2015
- Terminated
- December 3, 2015
- Recall Number
- Z-2823-2015
- Quantity
- 2,346
- Firm Location
- Louisville, CO
- Official Source
- View on FDA website ↗
Reason for Recall
Specific use conditions can increase the possibility of a screwdriver tip deforming or breaking during surgery.
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; Slovakia; Turkey; and South Africa.
Lot / Code Info
For this action, device lot numbers are not applicable. The action covers all lots of products distributed between September 2010 and July 2015
Root Cause
Labeling design
Action Taken
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.