Inion instrument 1Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI M224INS902910), received between Apr 1, 2026 and Apr 1, 2026 — classified as 1 injury.

The most frequently reported specific device problem is “Difficult to Insert” (1 report).

3 other recalls cover devices cleared under the same FDA submission (K010351, K010352); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryApr 1, 2026Difficult to Insert

  DURING A SURGICAL PROCEDURE WITH INION CPS AND CPS BABY IMPLANTS, THERE WAS A DELAY IN THE INITIAL OPERATION DUE TO SCREW PICKING AND INSERTION PROBLEMS WITH THE INION SCREWDRIVER. ADDITIONALLY, THE PATIENT HAS SUFFERED FROM POSTOPERATIVE INFECTION AND HAS GOT ANTIBIOTIC TREATMENT. A REOPERATION IS PLANNED TO REMOVE INION IMPLANTS AND REPLACE THEM WITH TITANIUM IMPLANTS.

  Patient problems: Unspecified Infection

  MAUDE report 24751932 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K010351, K010352. One submission often covers many models, so check the product and lot details in each record.

• Z-0630-2011 · Apr 14, 2010 · Terminated
  1.5 mm Inion CPS Baby, 4 hole plate, REF PLT-1000, sterile, Manufacturer, INION Oy, Finland.
• Z-0631-2011 · Apr 14, 2010 · Terminated
  1.5 mm Inion CPS Baby , 20 hole plate, REF PLT-1001, sterile, Manufacturer, INION Oy, Finland.
• Z-1550-2010 · Mar 5, 2010 · Terminated
  Inion 1.5 x 6mm CPS(R) Baby Screw, 1.5mm Inion CPS(R) Baby 5+E, REF SCR 1221, 5/pack, STERILE/R Stryker Craniomaxillofacial, Portage, MI. The INION CPS BABY 1.5 BIOABSORBABLE FIXA