Drug recall
Atlas Spine Torque Limiting Handle 6N-m, P/N 70089 Model # ITN-001-000 Used to rotate implant into position
FDA recall event 73657 · Class II · Atlas Spine, Inc.
Key facts
| Event ID | 73657 |
|---|---|
| Recall numbers | Z-1616-2016 |
| Recalling firm | Atlas Spine, Inc. |
| Product type | Devices |
| Products | Atlas Spine Torque Limiting Handle 6N-m, P/N 70089 Model # ITN-001-000 Used to rotate implant into position |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | The device was not appropriately set to mitigate the risk of implant fracture upon rotation inside the disc space. |
| Initiation date | Jul 26, 2013 |
| Report date | May 18, 2016 |
| Termination date | Jul 26, 2019 |
| City | Jupiter |
| State | FL |
| Country | United States |
| FEI number | 3003855635 |
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: