Facility

IN2BONES USA, LLC

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

Key facts

4recalls · 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)	3011580264
Establishment type	Manufacture Medical Device
Location	7750a Trinity Rd Cordova, TN, US 38018
Registration status	Active · expires 2026
Parent company	In2Bones USA, LLC (owner-operator 10049042)
Brand names	RTS Lesser MTP Implant System

Activity by year

Recalls (4)
Inspections (1)

Devices registered here (1)

Prosthesis, Toe, Constrained, Polymer
Product code KWH (opens in a new tab) · Class II · Orthopedic · 21 CFR 888.3720

Recalls & enforcement

Class IIOngoing2026-05-11
Due to the Magnetic Resonance Conditional Symbol missing on the carton, inner tray, and patient label.
Class IITerminated2021-08-18
Complaints were received of CoLink Bone Graft Harvesters breaking at the outer tube weld site.
Class IITerminated2018-11-14
The NeoSpan Compression Staple (10x10x10) kits from two lots contain the wrong size drill bit. They contain a 3mm drill bit instead of a 2mm drill bit.
Class IITerminated2018-07-16
CoLink(TM) Lapidus Plate +2mm Right and Left, were laser marked incorrectly. In these lots, right plates were laser marked as left plates and the left plates were laser marked as right plates.

FDA inspections (1)

VAI2019-03-08
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.

All facilities operated by In2Bones USA, 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. “IN2BONES USA, LLC (FEI 3011580264) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3011580264-in2bones-usa-llc/

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