RegWardenFDA facility compliance records
Company

Acuity Surgical Devices, LLC

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

Recalls by year

FDA actions on record by year2019: 1 recalls20172018120192020202120222023202420252026
  • Recalls (1)

Registered facilities (1)

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.

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. We restate the public record only — measured facts, never risk verdicts.

Cite this record

RegWarden. “Acuity Surgical Devices, LLC — FDA compliance profile.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/company/oo-10046711-acuity-surgical-devices-llc/

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