Facility

CPM Medical Consultants, LLC.

1 recall(s) on record — most severe on record: Class II.

Key facts

1recalls · worst Class II

1inspections · worst VAI

—warning letters in our data

Recalls are listed for the parent company: openFDA recall records do not name a facility. How we attribute records

FDA Establishment Identifier (FEI)	3007334927
Establishment type	Complaint File Establishment per 21 CFR 820.198; Develop Specifications But Do Not Manufacture At This Facility
Location	4343 Sigma Road Farmers Branch, TX, US 75244
Registration status	Active · expires 2026
Parent company	CPM Medical (owner-operator 10029470)
Brand names	STERIZO Total Hip System

Activity by year

Recalls (1)
Inspections (1)

Devices registered here (2)

Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
Product code LZO (opens in a new tab) · Class II · Orthopedic · 21 CFR 888.3353
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Product code LPH (opens in a new tab) · Class II · Orthopedic · 21 CFR 888.3358

Recalls & enforcement

Class IIOngoing2025-09-17
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 appl…

FDA inspections (1)

VAI2025-08-29
Voluntary Action Indicated · Compliance: Devices · citations posted

Source: U.S. FDA Inspections Dashboard (opens in a new tab) (device inspection classifications, 2016–present). Data as of 2026-10-06. The dashboard profile can take several seconds to load.

All facilities operated by CPM Medical

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

Cite this record

RegWarden. “CPM Medical Consultants, LLC. (FEI 3007334927) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3007334927-cpm-medical-consultants-llc/

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