Facility

Engineered Medical Systems, LLC

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

Key facts

1recalls · worst Class I

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)	3009973336
Establishment type	Manufacture Medical Device for Another Party (Contract Manufacturer)
Location	3325 Appling Rd Bartlett, TN, US 38133
Registration status	Active · expires 2026
Parent company	Engineered Medical Systems, LLC (owner-operator 10042524)
Brand names	TOTAL KNEE SYSTEM INSTRUMENTATION

Activity by year

Recalls (1)
Inspections (3)

Devices registered here (8)

Prosthesis, Knee, Patello/Femorotibial, Constrained, Cemented, Polymer/Metal/Polymer
Product code KRQ (opens in a new tab) · Class II · Orthopedic · 21 CFR 888.3550
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Product code JWH (opens in a new tab) · Class II · Orthopedic · 21 CFR 888.3560
Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer
Product code HSX (opens in a new tab) · Class II · Orthopedic · 21 CFR 888.3520
Prosthesis, Knee Patellofemorotibial, Partial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Product code NPJ (opens in a new tab) · Class II · Orthopedic · 21 CFR 888.3560
Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer
Product code KRR (opens in a new tab) · Class II · Orthopedic · 21 CFR 888.3540
Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
Product code MBH (opens in a new tab) · Class II · Orthopedic · 21 CFR 888.3565
Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer
Product code HRY (opens in a new tab) · Class II · Orthopedic · 21 CFR 888.3530
Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer
Product code KRO (opens in a new tab) · Class II · Orthopedic · 21 CFR 888.3510

Recalls & enforcement

Class ITerminated2011-09-12
The mask inside the package has been identified as "Neonatal" in size and not "Infant" as the labeling indicates.

FDA inspections (3)

NAI2025-09-16
No Action Indicated · Compliance: Devices
VAI2023-02-10
Voluntary Action Indicated · Compliance: Devices · citations posted
NAI2016-06-17
No Action Indicated · Compliance: 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 Engineered Medical Systems, 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. “Engineered Medical Systems, LLC (FEI 3009973336) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3009973336-engineered-medical-systems-llc/

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