P/N: 9735023 — Class II medical device recall Z-2823-2015
Terminated recall by Medtronic Navigation, Inc., reported 2015-10-07, distributed nationwide. Specific use conditions can increase the possibility of a screwdriver tip deforming or breaking during surgery
| Recall number | Z-2823-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medtronic Navigation, Inc., Louisville, CO, United States |
| Recall initiated | 2015-09-14 |
| Classified | 2015-09-30 |
| Reported by FDA | 2015-10-07 |
| Terminated | 2015-12-03 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AU, BE, CA, CH, CN, DE, DK, ES, FI, FR, GB, GR, IL, IN, IT, JP, NL, NZ, PL, PT, SE, SG, SK, TH, TR, ZA |
| Quantity | 2,346 |
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 for recall
Specific use conditions can increase the possibility of a screwdriver tip deforming or breaking during surgery.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2823-2015. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.