RegWardenFDA facility compliance records
Company

Gramercy Extremity Orthopedics, LLC.

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

Recalls by year

FDA actions on record by year2023: 1 recalls20172018201920202021202212023202420252026
  • Recalls (1)

Registered facilities (1)

Recalls & enforcement

  • Class IIOngoing2023-04-04
    Instrument Kits for EPS plates may contain drill guides with incorrect drill depth range of 30mm - 60mm; not the correct drill depth range of 10mm - 40mm.

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. “Gramercy Extremity Orthopedics, 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-10053967-gramercy-extremity-orthopedics-llc/

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