FEI 3007334927

Cpm Medical Consultants, Llc.

4343 Sigma Road, Farmers Branch, TX, US

MDR events1All time

Recalls1All time

Registered products8

Establishment typeComplaintComplaint File Establishment per 21 CFR 820.198

Registered product codes

8 product codes

Recent MDR events

1 on file

FUSE PEDICLE SCREW SYSTEMSep 24, 2025
Malfunction3007334927-2025-00001

Recalls

1 on file

Open, ClassifiedOct 21, 2025
Instructions for use for a foot plating system is being updated to remove the second option of requirements for sterilization which was 3 minutes exposure time at 134-137-degrees C (273-279-degrees F) and 40mBar for 5-10 minutes drying time, because these requirements do not apply in the United States.
View FDA record ↗

Compliance history

Matched by FEI 3007334927.

FDA inspections

1 on file

Voluntary Action Indicated (VAI)Aug 29, 2025
Compliance: Devices · Citations posted

Inspection citations

2 on file

Top cited requirements

Compare to industry ↗

21 CFR 803.50(a)(2)Aug 29, 2025
Individual Report of Malfunction
21 CFR 820.30(g)Aug 29, 2025
Design validation - user needs and intended uses

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.