Class II — Atlas Spine, Inc.
| Recalling firm | ATLAS SPINE INC. |
|---|---|
| Registered facility | ATLAS SPINE INC. (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | The device was not appropriately set to mitigate the risk of implant fracture upon rotation inside the disc space. |
| Product | Atlas Spine Torque Limiting Handle 6N-m, P/N 70089 Model # ITN-001-000 Used to rotate implant into position |
| Quantity | 16 |
| Distribution | Nationwide Distribution to FL, MO, and WV. |
| Initiated | 2013-07-26 |
| Classified | 2016-05-06 |
| Terminated | 2019-07-26 |
| Recall number | Z-1616-2016 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Atlas Spine, Inc. (Z-1616-2016).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/73657/
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