RegWardenFDA facility compliance records
Recall

Class II — ulrich medical USA Inc

Recalling firmULRICH MEDICAL USA, INC.
Registered facilityULRICH MEDICAL USA, INC. (the firm's only registered facility)
ClassificationClass II
StatusTerminated
ReasonCertain Torque Limiting Handles in the field are beyond their 3 year calibration life.
ProductULRICH Torque Limiting Handle for use with a Set Screw Driver to perform the final tightening of set screws in a spinal implant construct.
Quantity25
DistributionAZ, IL, LA, MI, MO, NV, OH, PA, TN, and TX.
Initiated2019-03-08
Classified2019-04-11
Terminated2020-07-10
Recall numberZ-1126-2019
InitiationVoluntary: Firm initiated

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)

Cite this record

RegWarden. “Class II recall — ulrich medical USA Inc (Z-1126-2019).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/82497/

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