Facility

GRAMERCY EXTREMITY ORTHOPEDICS, LLC.

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

Key facts

1recalls · worst Class II

3inspections · 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)	3012478585
Establishment type	Complaint File Establishment per 21 CFR 820.198; Manufacture Medical Device; Develop Specifications But Do Not Manufacture At This Facility
Location	1239 N Glenville Dr Richardson, TX, US 75081
Registration status	Active · expires 2026
Parent company	Gramercy Extremity Orthopedics, LLC. (owner-operator 10053967)
Brand names	J-Hook Depth Gauge; Depth Gauge

Activity by year

Recalls (1)
Inspections (3)

Devices registered here (1)

Gauge, Depth
Product code HTJ (opens in a new tab) · Class I · Orthopedic · 21 CFR 888.4300

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.

FDA inspections (3)

VAI2025-10-24
Voluntary Action Indicated · Compliance: Devices · citations posted
VAI2022-10-06
Voluntary Action Indicated · Compliance: Devices; Postmarket Assurance: Devices · citations posted
NAI2018-10-17
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.

All facilities operated by Gramercy Extremity Orthopedics, LLC.

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. “GRAMERCY EXTREMITY ORTHOPEDICS, LLC. (FEI 3012478585) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3012478585-gramercy-extremity-orthopedics-llc/

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