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Medtronic Navigation, Inc. recalls P/N: 9734856, SCREWDRIVER, 9734856, SOLERA STD MAST; P/N: 9734857, SCREWDRIVER, 9734857, SOLERA RDN MAST; P/N: 9734279,
Recalled October 7, 2015 · FDA recall Z-2824-2015 · Medtronic Navigation
Hazard
Specific use conditions can increase the possibility of a screwdriver tip deforming or breaking during surgery. · FDA Class II
Units
2346
Sold at
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.
Description
Specific use conditions can increase the possibility of a screwdriver tip deforming or breaking during surgery.
Product
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.
Manufacturer(s)
Medtronic Navigation, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →