PedFuse Reset Screw Inserters — Class II medical device recall Z-0553-2014
Terminated recall by SpineFrontier, Inc., reported 2014-01-01, distributed in FL, IL, NY, OH, TX, VA, WA. Screw inserters may not mate properly with hex interface of the screws.
| Recall number | Z-0553-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | SpineFrontier, Inc., Beverly, MA, United States |
| Recall initiated | 2013-11-20 |
| Classified | 2013-12-20 |
| Reported by FDA | 2014-01-01 |
| Terminated | 2018-06-26 |
| Distributed | FL, IL, NY, OH, TX, VA, WA |
| Quantity | 4 |
| Model numbers | 11-80110 |
Product
PedFuse Reset Screw Inserters; PedFuse Screw Inserter 05-7 REset Part #11-80110 The PedFuse Screw Inserter 05-7 REset, Screw Inserter 05-7 REspond, and Screw Inserter 08-9 REset are used as a screw capture, screw driver, and screw insertion tool in the PedFuse system.
Reason for recall
Screw inserters may not mate properly with hex interface of the screws.
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-0553-2014. 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.