Ti-Cron 88862947-53Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10884521105263), received between Sep 16, 2020 and May 1, 2025 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Break” (8 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 1, 2025Break; Material Frayed; Break; Material Frayed

  IT WAS REPORTED THAT THE SUTURE WAS NOT STRONG ENOUGH, IT BROKE BY SOME FORCE. THE TWO NEEDLES HAVE FRAYED SUTURES COMING FROM THE PROXIMAL ENDS. AN ADDITIONAL LENGTH OF SUTURE WAS ALSO HAS FRAYED AT BOTH ENDS. THE EVENT OCCURRED DURING LAB OR DEMO; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21941176 ↗
• MalfunctionApr 30, 2025Break; Break

  ACCORDING TO THE REPORTER, DURING A KNEE ARTHROSCOPY PROCEDURE, THREE (3) SWAGED NEEDLES WITH SUTURE SNAPPED WHEN THE SURGEON TIED THE KNOT OVER THE CAPSULE. THE SUTURES WERE REMOVED FROM THE PATIENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO DELAY USING A BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21937252 ↗
• MalfunctionApr 30, 2025Break; Break

  ACCORDING TO THE REPORTER, DURING A KNEE ARTHROSCOPY PROCEDURE, THREE (3) SWAGED NEEDLES WITH SUTURE SNAPPED WHEN THE SURGEON TIED THE KNOT OVER THE CAPSULE. THE SUTURES WERE REMOVED FROM THE PATIENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO DELAY USING A BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21937216 ↗
• MalfunctionApr 30, 2025Break; Break

  ACCORDING TO THE REPORTER, DURING A KNEE ARTHROSCOPY PROCEDURE, THREE (3) SWAGED NEEDLES WITH SUTURE SNAPPED WHEN THE SURGEON TIED THE KNOT OVER THE CAPSULE. THE SUTURES WERE REMOVED FROM THE PATIENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO DELAY USING A BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21937158 ↗
• MalfunctionApr 30, 2025Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY PROCEDURE, THE BLUE SUTURE OF THREE UNITS OF THE DEVICE BROKE WHILE TIGHTENING THE KNOT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A COMPETITOR'S DEVICE AND A SURGICAL DELAY OF LESS THAN 30 MINUTES. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21937037 ↗
• MalfunctionApr 30, 2025Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY PROCEDURE, THE BLUE SUTURE OF THREE UNITS OF THE DEVICE BROKE WHILE TIGHTENING THE KNOT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A COMPETITOR'S DEVICE AND A SURGICAL DELAY OF LESS THAN 30 MINUTES. NO FURTHER COMPLICATIONS WERE REPORTED.KL 4/30/2025

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21937013 ↗
• MalfunctionApr 30, 2025Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY PROCEDURE, THE BLUE SUTURE OF THREE UNITS OF THE DEVICE BROKE WHILE TIGHTENING THE KNOT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A COMPETITOR'S DEVICE AND A SURGICAL DELAY OF LESS THAN 30 MINUTES. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21936806 ↗
• MalfunctionApr 10, 2025Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY PROCEDURE, THE BLUE SUTURE OF THREE (3) UNITS OF THE TI-CRON BROKE WHILE TIGHTENING THE KNOT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A COMPETITOR'S DEVICE AND A SURGICAL DELAY OF LESS THAN 30 MINUTES. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21820673 ↗
• MalfunctionSep 16, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING KNEE ARTHROPLASTY, UPON PERFORMING MENISCUS SUTURE, THREAD DROPPED FROM THE NEEDLE. ANOTHER THREAD WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10540231 ↗

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-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-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-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-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-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