Facility

TREACE MEDICAL CONCEPTS, INC.

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

Key facts

1recalls · worst Class II

2inspections · worst NAI

—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)	3011623994
Establishment type	Manufacture Medical Device
Location	100 Palmetto Park Place PONTE VEDRA, FL, US 32081
Registration status	Active · expires 2026
Parent company	Treace Medical Concepts, Inc. (owner-operator 10050008)

Activity by year

Recalls (1)
Inspections (2)

Devices registered here (1)

Screw, Fixation, Bone
Product code HWC (opens in a new tab) · Class II · Orthopedic · 21 CFR 888.3040

Recalls & enforcement

Class IIOngoing2024-06-02
Potential issue causing a higher frequency of interference with locking screws and/or inserter rods than anticipated, resulting in screws stripping and/or not fully seating in the plates and/or interface issues between inserter rods and plates.

FDA inspections (2)

NAI2023-09-28
No Action Indicated · Compliance: Devices; Postmarket Assurance: Devices
NAI2017-07-12
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 Treace Medical Concepts, Inc.

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. “TREACE MEDICAL CONCEPTS, INC. (FEI 3011623994) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3011623994-treace-medical-concepts-inc/

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