FDA Device recall Z-2824-2015
P/N: 9734856, SCREWDRIVER, 9734856, SOLERA STD MAST
- FDA Device
- Class II
- terminated
- Published 2015-10-07
On 2015-10-07 the FDA classified a Class II recall of P/N: 9734856, SCREWDRIVER, 9734856, SOLERA STD MAST by Medtronic Navigation, citing specific use conditions can increase the possibility of a screwdriver tip deforming or breaking during surgery.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2824-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-09-14 |
| Published | 2015-10-07 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Medtronic Navigation |
| Distribution | US |
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 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.
Reason
Specific use conditions can increase the possibility of a screwdriver tip deforming or breaking during surgery.
Identifiers
| code_info | For this action, device lot numbers are not applicable. The action covers all lots of products distributed between September 2010 and July 2015 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2824-2015%22
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