FEI 3005532635
Ulrich Medical Usa, Inc.
3700 East Plano Parkway, Suite 200, Plano, TX, US
MDR events4All time
Recalls3All time
Registered products13
Establishment typeDevelopDevelop Specifications But Do Not Manufacture At This Facility
Registered product codes
13 product codes
Recent MDR events
4 on file
Recalls
3 on file
- TerminatedApr 26, 2017
Surgical technique was revised to prevent static plate screws blocking mechanisms from disassociating.
View FDA record ↗ - TerminatedUnknown
Certain Torque Limiting Handles in the field are beyond their 3 year calibration life.
View FDA record ↗ - TerminatedUnknown
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.
View FDA record ↗
Compliance history
Matched by FEI 3005532635.
FDA inspections
1 on file
- Voluntary Action Indicated (VAI)Mar 17, 2025
Compliance: Devices · Citations posted
Inspection citations
1 on file
Top cited requirements
Compare to industry ↗- 21 CFR 820.198(a)Mar 17, 2025
Lack of or inadequate complaint procedures
Compliance actions
0 on file
No warning letters or injunctions on file for this FEI number.
Import refusals
0 on file
No import refusals on file for this FEI number.