Ti-Cron 88862818-89Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10884521105157), received between Mar 4, 2020 and Jun 21, 2024 — classified as 5 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Unraveled Material” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryJun 21, 2024Break; Break

  ACCORDING TO THE REPORTER, 81 DAYS POST-OPERATIVE OF AN OPEN TOTAL HIP PROCEDURE WHERE THE SUTURES WERE USED FOR SKIN CLOSURE USING THE INTERRUPTED TIES SUTURING TECHNIQUE, THE PATIENT RETURNED TO THE HOSPITAL DUE TO WOUND DEHISCENCE. THE WOUND OPENED. A TOTAL OF 22 SUTURES WERE INVOLVED. AMONG THE 22 SUTURES, THE THREAD OF FOUR SYNTHETIC ABSORBABLE SUTURES BROKE. THE PATIENT WILL NEED TO COME BACK TO THE HOSPITAL FOR A REOPERATION FOR THE WOUND EXCISION/DEBRIDEMENT.

  Patient problems: Unspecified Tissue Injury; Wound Dehiscence

  MAUDE report 19588962 ↗
• MalfunctionJun 21, 2024Unraveled Material; Unraveled Material

  ACCORDING TO THE REPORTER, DURING AN OPEN TOTAL HIP RECONSTRUCTION PROCEDURE, WHILE CLOSING THE JOINT CAPSULE AND FASCIA, THE KNOTS UNRAVELED. THE ISSUE OCCURRED IN SEVEN SUTURES. THE SURGEON USED A NEW SUTURE AND COMPLETED THE PROCEDURE AS USUAL. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19586724 ↗
• MalfunctionJun 21, 2024Unraveled Material; Unraveled Material

  ACCORDING TO THE REPORTER, DURING AN OPEN TOTAL HIP RECONSTRUCTION PROCEDURE, WHILE CLOSING THE JOINT CAPSULE AND FASCIA, THE KNOTS UNRAVELED. THE ISSUE OCCURRED IN SEVEN SUTURES. THE SURGEON USED A NEW SUTURE AND COMPLETED THE PROCEDURE AS USUAL. THERE WAS NO PA TIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19585907 ↗
• MalfunctionJun 21, 2024Unraveled Material; Unraveled Material

  ACCORDING TO THE REPORTER, DURING AN OPEN TOTAL HIP RECONSTRUCTION PROCEDURE, WHILE CLOSING THE JOINT CAPSULE AND FASCIA, THE KNOTS UNRAVELED. THE ISSUE OCCURRED IN SEVEN SUTURES. THE SURGEON USED A NEW SUTURE AND COMPLETED THE PROCEDURE AS USUAL. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19585411 ↗
• InjuryJun 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, 81 DAYS POST-OPERATIVE OF AN OPEN TOTAL HIP PROCEDURE WHERE THE SUTURES WERE USED FOR SKIN CLOSURE USING THE INTERRUPTED TIES SUTURING TECHNIQUE, THE PATIENT RETURNED TO THE HOSPITAL DUE TO WOUND DEHISCENCE. THE WOUND OPENED. A TOTAL OF 22 SUTURES WERE INVOLVED. AMONG THE 22 SUTURES, THE THREAD OF FOUR SYNTHETIC ABSORBABLE SUTURES BROKE. THE PATIENT WILL NEED TO COME BACK TO THE HOSPITAL FOR A REOPERATION FOR THE WOUND EXCISION/DEBRIDEMENT.

  Patient problems: Unspecified Tissue Injury; Wound Dehiscence

  MAUDE report 19585002 ↗
• InjuryJun 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, 81 DAYS POST-OPERATIVE OF AN OPEN TOTAL HIP PROCEDURE WHERE THE SUTURES WERE USED FOR SKIN CLOSURE USING THE INTERRUPTED TIES SUTURING TECHNIQUE, THE PATIENT RETURNED TO THE HOSPITAL DUE TO WOUND DEHISCENCE. THE WOUND OPENED. A TOTAL OF 22 SUTURES WERE INVOLVED. AMONG THE 22 SUTURES, THE THREAD OF FOUR SYNTHETIC ABSORBABLE SUTURES BROKE. THE PATIENT WILL NEED TO COME BACK TO THE HOSPITAL FOR A REOPERATION FOR THE WOUND EXCISION/DEBRIDEMENT.

  Patient problems: Unspecified Tissue Injury; Wound Dehiscence

  MAUDE report 19584755 ↗
• InjuryJun 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, 81 DAYS POST-OPERATIVE OF AN OPEN TOTAL HIP PROCEDURE WHERE THE SUTURES WERE USED FOR SKIN CLOSURE USING THE INTERRUPTED TIES SUTURING TECHNIQUE, THE PATIENT RETURNED TO THE HOSPITAL DUE TO WOUND DEHISCENCE. THE WOUND OPENED. A TOTAL OF 22 SUTURES WERE INVOLVED. AMONG THE 22 SUTURES, THE THREAD OF FOUR SYNTHETIC ABSORBABLE SUTURES BROKE. THE PATIENT WILL NEED TO COME BACK TO THE HOSPITAL FOR A REOPERATION FOR THE WOUND EXCISION/DEBRIDEMENT.

  Patient problems: Unspecified Tissue Injury; Wound Dehiscence

  MAUDE report 19584277 ↗
• InjuryJun 20, 2024Unraveled Material; Unraveled Material

  ACCORDING TO THE REPORTER, IN A TOTAL RIGHT KNEE PROCEDURE, FOUR BRAIDED POLYESTER SUTURES UNRAVELED DURING THE JOINT CAPSULE CLOSURE AND SKIN CLOSURE. EIGHT OTHER SUTURES WERE USED FOR SKIN CLOSURE USING THE INTERRUPTED INSTRUMENT TIES STITCHING TECHNIQUE. POST-OPERATIVELY, THE PATIENT CAME BACK WITH WOUND DEHISCENCE. THE PATIENT WAS SCHEDULED TO RETURN FOR ANOTHER OPERATION TO DEBRIDE AND CLOSE THE WOUND.

  Patient problems: Unspecified Tissue Injury; Wound Dehiscence

  MAUDE report 19575766 ↗
• MalfunctionSep 2, 2021Break; Break

  ACCORDING TO THE REPORTER, PRE-OPERATIVELY, THE SUTURE BROKE. TO RESOLVE THE ISSUE, A NEW SUTURE WAS USED. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12418534 ↗
• MalfunctionMar 4, 2020Break; Break

  ACCORDING TO THE REPORTER, DURING AN OPEN PROCEDURE, THE SUTURE BROKE AFTER MAKING THE KNOT. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9785486 ↗

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-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-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-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-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-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