Facility

Acera Surgical, Inc. C/O Linda Braddon, PhD

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

Key facts

1recalls · worst Class II

2inspections · 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)	3012429393
Establishment type	Complaint File Establishment per 21 CFR 820.198; Develop Specifications But Do Not Manufacture At This Facility
Location	7842 Hickory Flat Hwy Ste B Woodstock, GA, US 30188
Registration status	Active · expires 2026
Parent company	Acera Surgical, Inc. (owner-operator 10051479)
Brand names	Cerafix® Dura Substitute

Activity by year

Recalls (1)
Inspections (2)

Devices registered here (1)

Dura Substitute
Product code GXQ (opens in a new tab) · Class II · Neurology · 21 CFR 882.5910

Recalls & enforcement

Class IITerminated2022-03-21
Misprinted expiration date on the shelf-box

FDA inspections (2)

VAI2024-06-07
Voluntary Action Indicated · Compliance: Devices; Postmarket Assurance: Devices · citations posted
NAI2018-11-13
No 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.

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. “Acera Surgical, Inc. C/O Linda Braddon, PhD (FEI 3012429393) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3012429393-acera-surgical-inc-c-o-linda-braddon-phd/

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