Facility

TOTAL JOINT ORTHOPEDICS, INC.

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

Key facts

1recalls · worst Class II

1inspections · 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)	3008544874
Establishment type	Complaint File Establishment per 21 CFR 820.198; Develop Specifications But Do Not Manufacture At This Facility
Location	1567 E. Stratford Avenue Salt Lake City, UT, US 84106
Registration status	Active · expires 2026
Parent company	Total Joint Orthopedics, Inc (owner-operator 10036774)
Brand names	Klassic® All-Poly Tibias, Ultra-PS®, Std Poly; Klassic® All-Poly Tibia, CR/Congruent, Std Poly

Activity by year

Recalls (1)
Inspections (1)

Devices registered here (1)

Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Product code JWH (opens in a new tab) · Class II · Orthopedic · 21 CFR 888.3560

Recalls & enforcement

Class IIOngoing2025-09-23
Potential packaging issue that could compromise the sterile barrier. Defect may result in loss of sterility of the device, presenting potential risk of infection if device is implanted.

FDA inspections (1)

NAI2018-04-18
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 Total Joint Orthopedics, 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. “TOTAL JOINT ORTHOPEDICS, INC. (FEI 3008544874) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3008544874-total-joint-orthopedics-inc/

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