RegWardenFDA facility compliance records
Facility

ACUITY SURGICAL DEVICES, LLC

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

Activity by year

FDA actions on record by year2019: 1 recalls, 1 inspections; 2025: 1 inspections201720182201920202021202220232024120252026
  • Recalls (1)
  • Inspections (2)

Devices registered here (1)

  • Intervertebral Fusion Device With Bone Graft, Lumbar
    Product code MAX (opens in a new tab) · Class II · Orthopedic · 21 CFR 888.3080

Recalls & enforcement

  • Class IIOngoing2019-01-07
    Due to a manufacturing process issue, it allowed vertebral body bone screws to not seat properly within the spinal device/cage.

FDA inspections (2)

  • VAI2025-01-27
    Voluntary Action Indicated · Compliance: Devices; Postmarket Assurance: Devices · citations posted
  • VAI2019-05-20
    Voluntary Action Indicated · Compliance: Devices; Postmarket Assurance: 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.

Related

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. “ACUITY SURGICAL DEVICES, LLC (FEI 3010866843) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3010866843-acuity-surgical-devices-llc/

Not open yet

Alerts for ACUITY SURGICAL DEVICES, LLC

Watchlist alerts will email you when FDA publishes a new recall, inspection classification, or warning letter for a facility you follow. They aren't open to the public yet — leave your email and we'll tell you when they are.

Planned

Want a one-page facility brief?

A single-page summary of this facility's registration and recall history for diligence. Not selling it yet — register interest and we'll follow up.