Facility

THEKEN COMPANIES, LLC

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

Key facts

1recalls · worst Class II

1inspections · 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)	3002498892
Establishment type	Develop Specifications But Do Not Manufacture At This Facility
Location	1800 Triplett Blvd Akron, OH, US 44306
Registration status	Active · expires 2026
Parent company	Theken Companies, LLC (owner-operator 10050903)
Brand names	INSERTERADAPTER

Activity by year

Recalls (1)
Inspections (1)

Devices registered here (1)

Orthopedic Manual Surgical Instrument
Product code LXH (opens in a new tab) · Class I · Orthopedic · 21 CFR 888.4540

Recalls & enforcement

Class IIOngoing2025-09-11
Downstream recall for RES 97605, BioPro femoral components. Product failed transit testing. Impacted product may have potential issues with sterile barrier.

FDA inspections (1)

VAI2018-12-13
Voluntary Action Indicated · Compliance: Devices; Postmarket Assurance: Devices · citations posted

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.

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. “THEKEN COMPANIES, LLC (FEI 3002498892) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3002498892-theken-companies-llc/

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