FDA recall Z-1126-2019

ulrich medical USA Inc · Class II · device

Product

ULRICH Torque Limiting Handle for use with a Set Screw Driver to perform the final tightening of set screws in a spinal implant construct.

Reason for recall

Certain Torque Limiting Handles in the field are beyond their 3 year calibration life.

Distribution

AZ, IL, LA, MI, MO, NV, OH, PA, TN, and TX.

Key facts

Status
Terminated
Initiation date
2019-03-08
Report date
2019-04-17
Termination date
2020-07-10
Voluntary/Mandated
Voluntary: Firm initiated
Location
Chesterfield, MO, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1126-2019