ulrich medical USA Inc recalls ULRICH Torque Limiting Handle for use with a Set Screw Driver to perform the final tightening of set screws in a spinal…
- Recall date
- March 8, 2019
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-1126-2019
- FDA classification
- Class II
- Brand / firm
- ulrich medical USA Inc
- Sold / distributed
- AZ, IL, LA, MI, MO, NV, OH, PA, TN, and TX.
Why it was recalled
Certain Torque Limiting Handles in the field are beyond their 3 year calibration life.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
ULRICH Torque Limiting Handle for use with a Set Screw Driver to perform the final tightening of set screws in a spinal implant construct.
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