Facility

MATRIX SURGICAL HOLDINGS, LLC dba MATRIX SURGICAL USA

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

Key facts

2recalls · 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)	3009383407
Establishment type	Manufacture Medical Device
Location	98 Bledsoe Road Newnan, GA, US 30265
Registration status	Active · expires 2026
Parent company	Matrix Surgical Holdings, LLC. dba Matrix Surgical USA (owner-operator 10038239)
Brand names	OMNIPORE(R) Surgical Implant

Activity by year

Recalls (2)
Inspections (1)

Devices registered here (1)

Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction
Product code KKY (opens in a new tab) · Class II · General, Plastic Surgery · 21 CFR 878.3500

Recalls & enforcement

Class IITerminated2019-01-30
Product mislabeling.
Class IITerminated2017-01-25
Mislabeling. The packaging labeled as left mandible contained a right mandible.

FDA inspections (1)

VAI2018-06-21
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 Matrix Surgical Holdings, LLC. dba Matrix Surgical USA

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. “MATRIX SURGICAL HOLDINGS, LLC dba MATRIX SURGICAL USA (FEI 3009383407) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3009383407-matrix-surgical-holdings-llc-dba-matrix-/

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