FDA-Device2016-05-18Class II
Atlas Spine Torque Limiting Handle 6N-m, P/N 70089 Model # ITN-001-000 Used to rotate implant into position
Atlas Spine, Inc.
Hazard
The device was not appropriately set to mitigate the risk of implant fracture upon rotation inside the disc space.
Sold states
Nationwide Distribution to FL, MO, and WV.
Affected count
16
Manufactured in
1555 Jupiter Park Dr Ste 4, N/A, Jupiter, FL, United States
Products
Atlas Spine Torque Limiting Handle 6N-m, P/N 70089 Model # ITN-001-000 Used to rotate implant into position
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1616-2016Don't want to check this manually?
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