P/N: 9734856 — Class II medical device recall Z-2824-2015
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-2824-2015 |
|---|---|
| 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: 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 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-2824-2015. 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.