Reported Mar 4, 2020 · Terminated
Ulrich medical neon3 OCT spinal stabilization, REF CS 3917-12, Locking screw for crosslink, screw-to-screw
ulrich medical USA 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: ulrich medical USA Inc · 18221 Edison Ave · Chesterfield, MO · 63005-3703
Is this the product you have?
- Ulrich medical neon3 OCT spinal stabilization, REF CS 3917-12, Locking screw for crosslink, screw-to-screw
- Lot codes and dates
- Lot Numbers
U010577U016620U019084
- Lot Numbers
- Amount recalled
- 179 units
Where it was sold
Why it was recalled
Due to a production error, the weld seam of the "Locking screw for crosslink, screw-to-screw" cannot reliably transmit the required torque of 3.5 Nm during installation.
This product could cause temporary or reversible health problems — stop using it.
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