FDA Device recall Z-1616-2016
Atlas Spine Torque Limiting Handle 6N-m, P/N 70089 Model # ITN-001-000 Used to rotate implant into position
- FDA Device
- Class II
- terminated
- Published 2016-05-18
On 2016-05-18 the FDA classified a Class II recall of Atlas Spine Torque Limiting Handle 6N-m, P/N 70089 Model # ITN-001-000 Used to rotate implant into position by Atlas Spine, citing the device was not appropriately set to mitigate the risk of implant fracture upon rotation inside the disc space.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1616-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-07-26 |
| Published | 2016-05-18 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Atlas Spine |
| Distribution | US |
Product
Atlas Spine Torque Limiting Handle 6N-m, P/N 70089 Model # ITN-001-000 Used to rotate implant into position
Reason
The device was not appropriately set to mitigate the risk of implant fracture upon rotation inside the disc space.
Identifiers
| code_info | Lots #: 8887, 000073, 000135, 00434, and 02518. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1616-2016%22
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