RegWardenFDA facility compliance records
Company

In2Bones SAS

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

Recalls by year

FDA actions on record by year2015: 2 recalls; 2016: 1 recalls; 2017: 1 recalls; 2021: 1 recalls; 2024: 1 recalls22015120161201720182019202012021202220231202420252026
  • Recalls (6)

Registered facilities (1)

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.

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. We restate the public record only — measured facts, never risk verdicts.

Cite this record

RegWarden. “In2Bones SAS — FDA compliance profile.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/company/oo-10046803-in2bones-sas/

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