Ti-Cron 88863271-41Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10884521062191), received between Mar 6, 2019 and Jul 28, 2025 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Break” (4 reports).

6 other recalls cover devices cleared under the same FDA submission (K930591); 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 28, 2025Break; Break

  ACCORDING TO THE REPORTER, DURING SKIN CLOSURE, THE SURGEON GENTLY PULLED THE SUTURE WITH A CURVED NEEDLE, AND IT BROKE IMMEDIATELY AS SOON AS IT WAS PULLED. THE DEFECTIVE SUTURE WAS IMMEDIATELY CUT AND REMOVED FROM THE SKIN, AND A NEW SUTURE WAS USED INSTEAD, TO COMPLETE THE CASE. THE SUTURE BREAKAGE LED TO PROLONGED SURGERY TIME.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 22628435 ↗
• InjuryDec 1, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, FOLLOWING DEBRIDEMENT AND SUTURING DUE TO TRAUMA, WHEN CHANGING THE DRESSING, IT WAS FOUND THAT THE SUTURES OF THE WOUND WERE EXPOSED AND THE WOUND DID NOT HEAL. DEBRIDEMENT AND DRESSING CHANGE WAS DONE ON THE WOUND AND THE SUTURE WAS REMOVED.

  Patient problems: Wound Dehiscence

  MAUDE report 12909672 ↗
• MalfunctionMar 8, 2019Break; Material Frayed; Break; Material Frayed

  ACCORDING TO THE REPORTER, DURING AN OPEN PROCEDURE, THE PHYSICIAN HAD AN ISSUE WITH THE SUTURE WHEREIN IT WAS FRAYING AND BREAKING WITH ROUTINE HANDLING OF THE DEVICE. THE PHYSICIAN IS WEARING LOOPS WHEN USING THE PRODUCT AND IT CAN BE SEEN THAT THE SUTURE IS FRAYING APART IN THE LOOPS WHEN TYING DOWN, RUNNING KNOTS OR THREADING THROUGH A FREE NEEDLE. THE PRODUCT IS CONTINUED TO BE USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8405884 ↗
• MalfunctionMar 8, 2019Break; Material Frayed; Break; Material Frayed

  ACCORDING TO THE REPORTER, DURING A EXTENSOR CARPI ULNARIS STABILIZATION PROCEDURE, THE SUTURE WAS FRAYING AND BREAKING WITH ROUTINE HANDLING. THE CASE WAS COMPLETED WITH PRODUCT. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8405386 ↗
• MalfunctionMar 6, 2019Break; Break

  ACCORDING TO THE REPORTER, HALFWAY ON AN OPEN PROCEDURE, THE SUTURE BROKE AFTER PASSING IT THROUGH THE EYELET OF A KEITH NEEDLE. ANOTHER SUTURE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8394568 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K930591. One submission often covers many models, so check the product and lot details in each record.

• Z-2830-2011 · Jun 3, 2011 · Terminated
  Syneture Ti-Cron 0 5X18" BLUE T-40/HGS-22 D-TACH, non-absorbable polyester sutures Material 8886337962 Ti-Cron is intended for use in general soft tissue approximation and/or lig
• Z-2828-2011 · Jun 3, 2011 · Terminated
  Syneture Ti-Cron 1 Blue 5x18 HGS-22 D-Tach non-absorbable polyester sutures Material 8886337272 Ti-Cron is intended for use in general soft tissue approximation and/or ligation, i
• Z-2829-2011 · Jun 3, 2011 · Terminated
  Syneture Ti-Cron 2 BLUE 5X18" HGS-22 non-absorbable polyester sutures Material 8886337282 Ti-Cron is intended for use in general soft tissue approximation and/or ligation, includi
• Z-2825-2011 · Jun 3, 2011 · Terminated
  Syneture Ti-Cron 0 BLUE 6X18" PRE-CUT non-absorbable polyester sutures Material 8886300162 Ti-Cron is intended for use in general soft tissue approximation and/or ligation, inclu
• Z-2827-2011 · Jun 3, 2011 · Terminated
  Syneture Ti-Cron 1 Blue 5x18 HGS-22 D-Tach non-absorbable polyester sutures Material 8886326062 Ti-Cron is intended for use in general soft tissue approximation and/or ligation, i
• Z-2826-2011 · Jun 3, 2011 · Terminated
  Syneture Ti-Cron 0 5X18" BLUE T-19/GS-22 D-TACH non-absorbable polyester sutures Material 8886325962 Ti-Cron is intended for use in general soft tissue approximation and/or ligat