Drug recall
PedFuse Reset Screw; Model: 01-80115-55 The PedFuse Reset pedicle screw implants intended to be used to help…
FDA recall event 66698 · Class II · SpineFrontier, Inc.
Key facts
| Event ID | 66698 |
|---|---|
| Recall numbers | Z-0544-2014 |
| Recalling firm | SpineFrontier, Inc. |
| Product type | Devices |
| Products | 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… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| 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… |
| Initiation date | Oct 18, 2013 |
| Report date | Dec 25, 2013 |
| Termination date | Aug 22, 2016 |
| City | Beverly |
| State | MA |
| Country | United States |
| FEI number | 3005977257 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: