Medtronic Navigation, Inc.: Medical Device Recall in 2015 - (Recall #: Z-2823-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: September 14, 2015

Date Posted: October 7, 2015

Recall Number: Z-2823-2015

Event ID: 72183

Reason for Recall:

Specific use conditions can increase the possibility of a screwdriver tip deforming or breaking during surgery.

Status: Terminated

Product Quantity: 2,346

Code Information:

For this action, device lot numbers are not applicable. The action covers all lots of products distributed between September 2010 and July 2015

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated