Medtronic Navigation, Inc.: Medical Device Recall in 2015 - (Recall #: Z-2824-2015)

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: 9734856, SCREWDRIVER, 9734856, SOLERA STD MAST; P/N: 9734857, SCREWDRIVER, 9734857, SOLERA RDN MAST; P/N: 9734279, SCREWDRIVER 9734279 SOLERA STANDARD; and P/N: 9734373, SCREWDRIVER 9734373 SOLERA REDUCTION. 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-2824-2015

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: 2346

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