Chesterfield, MO, United States
ulrich medical USA Inc recalls
2 recalls recorded since 2018, most recently on 31 December 2019. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls2
Ongoing (FDA)0
Terminated or completed2
Class I (FDA)0
Terminated Class II Medical devices
- Recall started
- 31 December 2019
- Terminated
- 17 November 2025
- Reason
- Due to a production error, the weld seam of the "Locking screw for crosslink, screw-to-screw" cannot reliably transmit the required torque of 3.5 Nm during installation.
- Distribution
- AZ, TX, GA, FL, AR, CA
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1350-2020
- Ulrich medical neon3 OCT spinal stabilization, REF CS 3917-12, Locking screw for crosslink, screw-to-screw
Terminated Class II Medical devices
- Recall started
- 8 March 2019
- Terminated
- 10 July 2020
- Reason
- 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.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1126-2019
- ULRICH Torque Limiting Handle for use with a Set Screw Driver to perform the final tightening of set screws in a spinal implant construct.
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.