Reported Oct 7, 2015 · Terminated
P/N: 9734856, SCREWDRIVER, 9734856, SOLERA STD MAST; P/N: 9734857, SCREWDRIVER, 9734857, SOLERA RDN MAST; P/N: 9734279,…
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?
4 of 4 products
| Model / number | Product as published |
|---|---|
9734856 | SCREWDRIVER, 9734856, SOLERA STD MAST |
9734857 | SCREWDRIVER, 9734857, SOLERA RDN MAST |
9734279 | SCREWDRIVER 9734279 SOLERA STANDARD |
9734373 | and , 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. |
- 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
- 2346
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.
Want the full recall guide?
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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