lnline Persuader- PedFuse Pedicle Screw System — Class II medical device recall Z-0977-2015
Terminated recall by SpineFrontier, Inc., reported 2015-01-21, distributed nationwide. A crack may develop in the handle to the Inline Persuader, which may progress if the user continues to use the
| Recall number | Z-0977-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | SpineFrontier, Inc., Beverly, MA, United States |
| Recall initiated | 2014-12-19 |
| Classified | 2015-01-14 |
| Reported by FDA | 2015-01-21 |
| Terminated | 2016-01-11 |
| Distributed | Nationwide (US) |
| Quantity | 4 devices |
| Reason classes | packaging |
| Serial numbers | 06440-0000, 06441-0000, AG24 |
| Model numbers | 11-80164 |
Product
lnline Persuader- PedFuse Pedicle Screw System; Part Number: 11-80164
Reason for recall
A crack may develop in the handle to the Inline Persuader, which may progress if the user continues to use the affected instrument.
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-0977-2015. 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.