Data Foundry

Medical device recalls 2019

ULRICH Torque Limiting Handle for use with a Set Screw Driver to… — Class II medical device recall Z-1126-2019

Terminated recall by ulrich medical USA Inc, reported 2019-04-17, distributed in AZ, IL, LA, MI, MO, NV, OH, PA…. Certain Torque Limiting Handles in the field are beyond their 3 year calibration life.

Recall numberZ-1126-2019
Product typeMedical device
ClassificationClass II
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmulrich medical USA Inc, Chesterfield, MO, United States
Recall initiated2019-03-08
Classified2019-04-11
Reported by FDA2019-04-17
Terminated2020-07-10
DistributedAZ, IL, LA, MI, MO, NV, OH, PA, TN, TX
Quantity25
UPC / GTIN / UDI-DI04052536022076, 04052536078301, 04052536078318, 04052536123704, 04052536123728
Serial numbers03-12-006-24, 03-12-006-25, J04192-056, J04192-064
Model numbers7130, 7134, 7146, 7148, 8049

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.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1126-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.