Facility

ULRICH MEDICAL USA, INC.

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

Key facts

3recalls · worst Class II

3inspections · 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)	3005532635
Establishment type	Develop Specifications But Do Not Manufacture At This Facility
Location	3700 East Plano Parkway, Suite 200 Plano, TX, US 75074
Registration status	Active · expires 2026
Parent company	ULRICH MEDICAL USA, INC. (owner-operator 9062154)
Brand names	Control Handle

Activity by year

Recalls (3)
Inspections (3)

Devices registered here (1)

Orthopedic Manual Surgical Instrument
Product code LXH (opens in a new tab) · Class I · Orthopedic · 21 CFR 888.4540

Recalls & enforcement

Class IITerminated2019-12-31
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.
Class IITerminated2019-03-08
Certain Torque Limiting Handles in the field are beyond their 3 year calibration life.
Class IITerminated2017-03-07
Surgical technique was revised to prevent static plate screws blocking mechanisms from disassociating.

FDA inspections (3)

VAI2025-03-17
Voluntary Action Indicated · Compliance: Devices · citations posted
VAI2019-03-06
Voluntary Action Indicated · Compliance: Devices; Postmarket Assurance: Devices
VAI2017-01-12
Voluntary Action Indicated · Compliance: Devices; Postmarket Assurance: Devices

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 ULRICH MEDICAL USA, INC.

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. “ULRICH MEDICAL USA, INC. (FEI 3005532635) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3005532635-ulrich-medical-usa-inc/

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