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.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product (surgical instrument) where injury has not yet been reported, fitting the criteria for a High severity score.
Plain-English summary
Medtronic Navigation, Inc. is recalling 2,346 units of the Navigated Solera Screwdrivers. These reusable medical devices are designed for use in spine surgery to assist in the placement of screws using a Medtronic computer-assisted surgery system. The recall covers four specific part numbers: 9734856, 9734857, 9734279, and 9734373.
The recall is being conducted because specific use conditions can increase the possibility of a screwdriver tip deforming or breaking during surgery. The action covers all lots of these products distributed between September 2010 and July 2015. The devices were distributed nationwide in the United States and internationally to numerous countries, including Canada, Australia, Germany, and Japan.
Healthcare facilities and users of these devices should stop using the affected screwdrivers and contact Medtronic Navigation for further instructions on the recall process.
The recalled product
- 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
- Manufacturer
- Medtronic Navigation, Inc.
- Hazard
- Affected units
- 2,346
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- For this action
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Medtronic Navigation, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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