Medical device recalls Moderate risk

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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