PedFuse Bone Probe — Class II medical device recall Z-0624-2014
Terminated recall by SpineFrontier, Inc., reported 2014-01-15, distributed in TX, VA. Bone Probes used to create a pathway in pedicle bone were manufactured and marked to incorrect specifications.
| Recall number | Z-0624-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | SpineFrontier, Inc., Beverly, MA, United States |
| Recall initiated | 2013-09-11 |
| Classified | 2014-01-03 |
| Reported by FDA | 2014-01-15 |
| Terminated | 2014-10-08 |
| Distributed | TX, VA |
| Quantity | 13 devices |
| Lot numbers | 012212-001 |
| Model numbers | SI81008 |
Product
PedFuse Bone Probe; Part: SI81008 spinal pedicle fixation.
Reason for recall
Bone Probes used to create a pathway in pedicle bone were manufactured and marked to incorrect specifications.
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-0624-2014. 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.