The Recall Desk

FDA (Devices) recall action 72183

Medtronic Navigation, Inc. recalled 2 products on 2015-10-07

The FDA (Devices) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.

Products
2
Announced
2015-10-07
Critical
0
Units
4,692

Why these products were recalled

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

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–2 of 2

  • HighFDA (Devices)··2015-10-07

    Medtronic Navigated Solera Screwdrivers Recalled for Potential Tip Deformation

    Medtronic Navigation is recalling 2,346 Navigated Solera Screwdrivers used in spine surgery because specific use conditions may cause the tips to deform or break.

    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
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2015-10-07

    Medtronic Solera Screwdrivers Recalled for Tip Deformation Risk

    Medtronic Navigation is recalling 2,346 Solera screwdrivers used in spine surgery because specific conditions may cause the tips to deform or break.

    Product
    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 Navig
    Category
    Distribution
    0 states