Reported May 18, 2016 · Terminated
Atlas Spine Torque Limiting Handle 6N-m, P/N 70089 Model # ITN-001-000 Used to rotate implant into position
Atlas Spine, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Atlas Spine, Inc. · 1555 Jupiter Park Dr Ste 4 · Jupiter, FL · 33458-8085
Is this the product you have?
- Atlas Spine Torque Limiting Handle 6N-m, P/N 70089 Model # ITN-001-000 Used to rotate implant into position
- Lot codes and dates
Lots #: 888700007300013500434and 02518
- Amount recalled
- 16
Where it was sold
Why it was recalled
The device was not appropriately set to mitigate the risk of implant fracture upon rotation inside the disc space.
This product could cause temporary or reversible health problems — stop using it.
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