Atlas Spine Torque Limiting Handle 6N-m — Class II medical device recall Z-1616-2016
Terminated recall by Atlas Spine, Inc., reported 2016-05-18, distributed nationwide. The device was not appropriately set to mitigate the risk of implant fracture upon rotation inside the disc sp
| Recall number | Z-1616-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Atlas Spine, Inc., Jupiter, FL, United States |
| Recall initiated | 2013-07-26 |
| Classified | 2016-05-06 |
| Reported by FDA | 2016-05-18 |
| Terminated | 2019-07-26 |
| Distributed | Nationwide (US) |
| Quantity | 16 |
| Reason classes | device malfunction |
| Lot numbers | 000073, 000135, 00434, 02518, 8887 |
| Model numbers | ITN-001-000 |
Product
Atlas Spine Torque Limiting Handle 6N-m, P/N 70089 Model # ITN-001-000 Used to rotate implant into position
Reason for recall
The device was not appropriately set to mitigate the risk of implant fracture upon rotation inside the disc space.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1616-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.