FDA Device recall Z-2823-2015
P/N: 9735023, DRIVER 9735023 SOLERA 5.5/6.0 MAS
- FDA Device
- Class II
- terminated
- Published 2015-10-07
On 2015-10-07 the FDA classified a Class II recall of P/N: 9735023, DRIVER 9735023 SOLERA 5.5/6.0 MAS 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-2823-2015 |
| 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: 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 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-2823-2015%22
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