FDA Device recall Z-0544-2014
PedFuse Reset Screw
- FDA Device
- Class II
- terminated
- Published 2013-12-25
On 2013-12-25 the FDA classified a Class II recall of PedFuse Reset Screw by Spinefrontier, citing 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 h….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0544-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-10-18 |
| Published | 2013-12-25 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Spinefrontier |
| Distribution | TX, VA |
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
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.
Identifiers
| code_info | Lot/Serial Numbers: 357305-000 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0544-2014%22
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