PedFuse Reset Screw — Class II medical device recall Z-0544-2014
Terminated recall by SpineFrontier, Inc., reported 2013-12-25, distributed in TX, VA. During routine servicing, it was discovered that one 8mmx55mm Reset screw was assembled with an 8mm tulip head
| Recall number | Z-0544-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | SpineFrontier, Inc., Beverly, MA, United States |
| Recall initiated | 2013-10-18 |
| Classified | 2013-12-19 |
| Reported by FDA | 2013-12-25 |
| Terminated | 2016-08-22 |
| Distributed | TX, VA |
| Quantity | 35 devices |
| Serial numbers | 357305-000 |
| Model numbers | 01-80115-55 |
Product
PedFuse Reset Screw; Model: 01-80115-55 The PedFuse Reset pedicle screw implants intended to be used to help provide immobilization and stabilization of spinal segments as an adjunct to fusion of the thoracic, lumbar, and/or sacral spine.
Reason for recall
During routine servicing, it was discovered that one 8mmx55mm Reset screw was assembled with an 8mm tulip head and a 9mm screw. The implant should have consisted of an 8mm tulip head and an 8mm screw. A recall was initiated to remove all remaining screws of the same lot from the field to investigate the nonconformity.
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-0544-2014. 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.