Reported Oct 7, 2015 · Terminated
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,…
Medtronic Navigation, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Medtronic Navigation, Inc. · 826 Coal Creek Cir · Louisville, CO · 80027-9710
Is this the product you have?
5 of 5 products
| Model / number | Product as published |
|---|---|
9735023 | DRIVER 9735023 SOLERA 5.5/6.0 MAS |
9735024 | DRIVER 9735024 SOLERA 5.5/6.0 MAS CAN |
9735025 | DRIVER 9735025 SOLERA 5.5/6.0 RMAS |
9735026 | DRIVER 9735026 SOLERA 5.5/6.0 RMAS CAN |
9735027 | DRIVER 9735027 SOLERA 5.5/6.0 FAS/SAS. 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. |
- Lot codes and dates
- For this action, device lot numbers are not applicable. The action covers all lots of products distributed between September 2010 and July 2015
- Amount recalled
- 2,346
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
Why it was recalled
Specific use conditions can increase the possibility of a screwdriver tip deforming or breaking during surgery.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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