Ti-Cron 88863027-79Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10884521059153), received between Jun 14, 2019 and Oct 4, 2023 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Product Quality Problem” (3 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 18, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 4, 2023Product Quality Problem; Use of Device Problem; Product Quality Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, DURING OPEN KNEE LIGAMENT SURGERY, THE FIBER FEELING WAS LOST AND THE SURFACE BECAME SLIPPER, MAKING THE SUTURE DIFFICULT TO HANDLE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17869775 ↗
• MalfunctionSep 28, 2021Break; Product Quality Problem; Break; Product Quality Problem

  ACCORDING TO THE REPORTER, WHEN A NEW BOX WAS OPENED, IT WAS NOTICED THAT THE DEVICE HAD MORE COIL TO THE STRAND, AND IT WAS A LOT THICKER. IT WAS ALSO NOTED THAT THE SUTURE BROKE DUE TO THICKNESS AND STIFFNESS WHEN ANCHORING DOWN WITH A SCREW. ANOTHER SUTURE FROM AN OLDER BOX WAS OPENED TO RESOLVE THE ISSUE AND IT WAS NOTED TO BE THINNER WITH LESS COIL.

  Patient problems: Insufficient Information

  MAUDE report 12543981 ↗
• MalfunctionJun 29, 2021Product Quality Problem; Unraveled Material; Use of Device Problem; Human-Device Interface Problem; Product Quality Problem; Unraveled Material; Use of Device Problem; Human-Device Interface Problem

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, THE SUTURE WAS TOO COATED. THE SURGEON WAS UNABLE TO TIE A KNOT AS THE SUTURE WILL NOT STAY IN PLACE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12089818 ↗
• InjuryJun 14, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, 28 DAYS POSTOPERATIVE FROM A LEFT ACHILLES TENDON ANASTOMOSIS, A SMALL AMOUNT OF EFFUSION WAS FOUND IN THE WOUND, AND THE INFLAMMATORY REACTION REQUIRED TREATMENT WITH DEBRIDEMENT AND DRESSING CHANGE. THE VISIBLE SUTURE IN THE WOULD WAS REMOVED.

  Patient problems: No Code Available

  MAUDE report 8701603 ↗

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-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
• 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-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-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-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