Atlas Spine, Inc. recalls Atlas Spine Torque Limiting Handle 6N-m, P/N 70089 Model # ITN-001-000 Used to rotate implant into position
- Recall date
- July 26, 2013
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-1616-2016
- FDA classification
- Class II
- Brand / firm
- Atlas Spine, Inc.
- Sold / distributed
- Nationwide Distribution to FL, MO, and WV.
Why it was recalled
The device was not appropriately set to mitigate the risk of implant fracture upon rotation inside the disc space.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
Atlas Spine Torque Limiting Handle 6N-m, P/N 70089 Model # ITN-001-000 Used to rotate implant into position
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