The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-2823-2015·Announced 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.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

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 medical device with a risk of harm (tip deformation or breakage) during surgery, but the source text does not report any specific injuries or illnesses, fitting the criteria for a High severity score.

Plain-English summary

Medtronic Navigation, Inc. is recalling 2,346 units of the Medtronic Navigated Solera Screwdrivers. The affected products include part numbers 9735023, 9735024, 9735025, 9735026, and 9735027. These reusable 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 all lots of these products distributed between September 2010 and July 2015.

The recall was initiated because specific use conditions can increase the possibility of a screwdriver tip deforming or breaking during surgery. The devices were distributed nationwide in the United States and internationally to Canada, the United Arab Emirates, Australia, Belgium, Switzerland, China, Germany, Denmark, Spain, Finland, France, Great Britain, Greece, India, Israel, Italy, Japan, the Netherlands, New Zealand, Poland, Portugal, Sweden, Singapore, Thailand, Slovakia, Turkey, and South Africa.

Healthcare providers and facilities that have these devices should stop using them and contact Medtronic Navigation for instructions on how to return or dispose of the products.

The recalled product

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…
Manufacturer
Medtronic Navigation, Inc.
Category
Medical Device — Surgical Instrument
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.

See all 2 products in this recall →

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