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Atlas Spine, Inc. recalls Atlas Spine Torque Limiting Handle 6N-m, P/N 70089 Model # ITN-001-000 Used to rotate implant into position
Recalled May 18, 2016 · FDA recall Z-1616-2016 · Atlas Spine
Hazard
The device was not appropriately set to mitigate the risk of implant fracture upon rotation inside the disc space. · FDA Class II
Units
16
Sold at
Nationwide Distribution to FL, MO, and WV.
Description
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
Manufacturer(s)
Atlas Spine, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →