RegWardenFDA facility compliance records
Company

In2Bones USA, LLC

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

Recalls by year

FDA actions on record by year2018: 2 recalls; 2021: 1 recalls; 2026: 1 recalls2017220182019202012021202220232024202512026
  • Recalls (4)

Registered facilities (1)

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.

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 USA, LLC — 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-10049042-in2bones-usa-llc/

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