Facility

OSTEOMED

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

Key facts

3recalls · 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)	2027754
Establishment type	Complaint File Establishment per 21 CFR 820.198; Manufacture Medical Device
Location	3885 Arapaho Rd ADDISON, TX, US 75001
Registration status	Active · expires 2026
Parent company	OSTEOMED (owner-operator 9000613)
Brand names	Sharp Hook

Activity by year

Recalls (3)
Inspections (3)

Devices registered here (1)

Hook, Bone
Product code KIK (opens in a new tab) · Class I · General, Plastic Surgery · 21 CFR 878.4800

Recalls & enforcement

Class IIOngoing2023-05-31
Screws for osteotomies have contain an undersize screwhead which has the potential to pass through the plate hole.
Class IIOngoing2021-10-28
Due to consoles not in compliance with the latest electrical safety standards IEC 60601 and as a result shocked a patient.
Class IITerminated2020-04-02
Incorrect shelf-life for bone void filler kits; the product may not maintain its setting characteristics for the labeled shelf-life duration.

FDA inspections (3)

NAI2025-08-08
No Action Indicated · Compliance: Devices; Postmarket Assurance: Devices
NAI2023-08-28
No Action Indicated · Compliance: Devices; Postmarket Assurance: Devices
NAI2017-09-22
No 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.

All facilities operated by OSTEOMED

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. “OSTEOMED (FEI 2027754) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/2027754-osteomed/

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