IBS™ S25 ST022Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 03760225710142), received between Sep 19, 2025 and Sep 19, 2025 — classified as 1 injury.

The most frequently reported specific device problem is “Material Twisted/Bent” (1 report).

3 other recalls cover devices cleared under the same FDA submission (K131920); 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.

• InjurySep 19, 2025Material Twisted/Bent; Adverse Event Without Identified Device or Use Problem; Material Twisted/Bent; Adverse Event Without Identified Device or Use Problem

  DEVICE DESCRIPTION: THE I.B.S®-C COMPRESSION OSTEOSYNTHESIS SCREWS ARE INTENDED FOR THE FIXATION OF ARTHRODESIS, OSTEOTOMIES OR FRACTURES OF LONG OR SHORT BONES OF THE UPPER AND LOWER LIMBS. THE SIZE OF THE CHOSEN SCREW SHOULD BE ADAPTED TO THE SPECIFIC INDICATIONS. EVENT DESCRIPTION: ON (B)(6) 2024, CONMED CUSTOMER SERVICE RECEIVED AN EMAIL FROM A PATIENT REPORTING A SERIOUS INCIDENT INVOLVING AN IMPLANTED ORTHOPEDIC SCREW. THE PATIENT UNDERWENT SURGERY IN (B)(6) 2023 DURING WHICH SIX IBS 2.5-C COMPRESSION SCREWS (DIAMETER 2.5 MM, LENGTH 22 MM, T7) WERE IMPLANTED IN THE TOES. ON (B)(6) 2024, THE PATIENT EXPERIENCED AN EVENT WHILE GETTING INTO BED, DURING WHICH THE MIDDLE TOE BECAME CAUGHT IN A RUG. THIS RESULTED IN THE BENDING OF ONE OF THE IMPLANTED SCREWS AND A DAMAGE OF THE TOE. THE PATIENT UNDERWENT A REVISION SURGERY TO REMOVE THE BENT SCREW AND REPLACE IT WITH ALTERNATIVE HARDWARE. THE EMAIL INCLUDED A PHOTO OF THE AFFECTED TOE AND THE BENT SCREW. NOTE: THIS REPORTABLE EVENT IS PART OF A REMEDITION RESULTING FROM A 483 LETTER.

  Patient problems: Fall

  MAUDE report 23096700 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K131920. One submission often covers many models, so check the product and lot details in each record.

• Z-1319-2024 · Jan 26, 2024 · Open, Classified
  I.B.S 6.5-C Compression screw - diam 6.5mm lg 75mm,Part Number S65 ST175
• Z-1320-2024 · Jan 26, 2024 · Open, Classified
  I.B.S 6.5-C Compression screw - diam 6.5mm lg 80mm,Part Number S65 ST180
• Z-0397-2016 · Nov 18, 2015 · Terminated
  IBS - Osteosynthesis screws for bone fixation Model S25 ST014.