Atlas Spine Torque Limiting Handle 6N-m, P/N 70089 Model # ITN-001-000 Used to rotate recall — FDA Z-1616-2016
The device was not appropriately set to mitigate the risk of implant fracture upon rotation inside the disc space.
Overview of recall records associated with Atlas Spine, Inc., including dates, categories and classifications where available.
Classification mix: Class II: 1.
The device was not appropriately set to mitigate the risk of implant fracture upon rotation inside the disc space.
This page summarizes recall records in which the official source identifies Atlas Spine, Inc. as the recalling firm or manufacturer. The number of records should not be treated as a safety rating or a measure of company size, because recall counts depend on product mix, reporting periods and how government records are organized.
Compare the dates, categories and classifications together rather than relying on the total alone. Open an individual record for the recalled product, reason, distribution details and current instructions available from the source.