Facility

Ortho Solutions Inc

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

Key facts

4recalls · worst Class II

—inspections in our data

—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)	3022270316
Establishment type	Complaint File Establishment per 21 CFR 820.198
Location	209 10th Avenue S Nashville, TN, US 37203
Registration status	Active · expires 2026
Parent company	ORTHO SOLUTIONS INC (owner-operator 10042129)
Brand names	ORTHO SOLUTIONS OXFORD ANKLE FUSION NAIL SYSTEM

Activity by year

Recalls (4)

Devices registered here (1)

Rod, Fixation, Intramedullary And Accessories
Product code HSB (opens in a new tab) · Class II · Orthopedic · 21 CFR 888.3020

Recalls & enforcement

Class IITerminated2017-10-10
Following the identification of corrosion residue found inside the cannulated devices in Forefoot and Midfoot trays Orhto Solutions Group has taken the decision to recall ALL x106 System 26 Forefoot and Midfoot Implants and Instruments tray from the US market.
Class IITerminated2017-04-19
There is a material mislabeling of the AFN End Cap.
Class IITerminated2016-07-21
Mislabeling of a single batch of FPS 3.5 x 35 mm Locking Screw as being Non-Locking Screws.
Class IITerminated2015-07-14
Ortho Solutions Inc is initiating a recall on behalf of UltOS 3.5mm locking screw. The locking thread feature of the screw was not manufactured to specification. As a consequence there is a risk that a screw may not lock onto the plate at the time of primary insertion into the p…

All facilities operated by ORTHO SOLUTIONS 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. “Ortho Solutions Inc (FEI 3022270316) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3022270316-ortho-solutions-inc/

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