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FDAJuly 26, 2013device

Atlas Spine Torque Limiting Handle 6N-m, P/N 70089 Model # ITN-001-000 Used to rotate implant into position

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

The device was not appropriately set to mitigate the risk of implant fracture upon rotation inside the disc space.

What to do

FDA enforcement status: Terminated

Brands named

atlas spineatlas

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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