Facility

In2Bones SAS

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

Key facts

6recalls · worst Class II

2inspections · 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)	3010470577
Establishment type	Develop Specifications But Do Not Manufacture At This Facility; Export Device to the United States But Perform No Other Operation on Device
Location	Immeuble Sequoia 3 Saint-Priest Rhone, FR 69800
Registration status	Active · expires 2026
Parent company	In2Bones SAS (owner-operator 10046803)
Brand names	GENERIC LID REUSABLE INSTRUMENTS

Activity by year

Recalls (6)
Inspections (2)

Devices registered here (1)

Staple Driver
Product code HXJ (opens in a new tab) · Class I · Orthopedic · 21 CFR 888.4540

Recalls & enforcement

Class IIOngoing2024-01-26
This Field Action is being conducted following the identification of a batch mix-up between I.B.S Compression screws diameter 6.5mm length 75mm and I.B.S Compression screws diameter 6.5mm length 80mm. The screws of the batches concerned by the recall may have different lengths f…
Class IITerminated2021-02-09
This Field Action is being conducted following identification of manufacturing non-conformity of some batches of Shannon burrs diameter 2.0mm length 20mm, possibly causing the breakage of the burr during use.
Class IITerminated2017-07-13
The firm received several customer complaints reporting some perioperative breakages of NE0411 Non-Locking screws when inserting the screw into the radius diaphysis
Class IITerminated2016-12-19
Dimensional non-conformity of the thread on the screw head.
Class IITerminated2015-11-18
One batch of osteosynthesis screws were manufactured with the incorrect Torx imprint on the screw head.
Class IITerminated2015-03-09
Dimensional non-conformity leading to the impossibility to introduce the implant in the dedicated holder.

FDA inspections (2)

VAI2025-09-04
Voluntary Action Indicated · Compliance: Devices; Postmarket Assurance: Devices · citations posted
NAI2016-10-27
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 In2Bones SAS

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 SAS (FEI 3010470577) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3010470577-in2bones-sas/

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