A-CIFT SoloFuse Fixed Angle Driver — Class II medical device recall Z-1973-2019
Terminated recall by SpineFrontier, Inc., reported 2019-07-24, distributed in AZ, FL, MD, MO. There is a potential for the driver to bind up when attempting to advance the intervertebral body fixation scr
| Recall number | Z-1973-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | SpineFrontier, Inc., Malden, MA, United States |
| Recall initiated | 2019-06-13 |
| Classified | 2019-07-12 |
| Reported by FDA | 2019-07-24 |
| Terminated | 2020-05-11 |
| Distributed | AZ, FL, MD, MO |
| Quantity | 6 |
| Lot numbers | EC20 |
| Model numbers | 13-32101-01, 14-32106, 14-32107-01 |
Product
A-CIFT SoloFuse Fixed Angle Driver, Model Number 13-32101-01 (Component Part Numbers 14-32107-01 and 14-32106)
Reason for recall
There is a potential for the driver to bind up when attempting to advance the intervertebral body fixation screw.
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-1973-2019. 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.