Ti-Cron 88863097-71Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 10884521060043), received between Jan 3, 2020 and Jun 24, 2024 — classified as 15 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Unraveled Material” (12 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 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• InjuryJun 24, 2024Unraveled Material; Unraveled Material

  ACCORDING TO THE REPORTER, POST-OPERATIVELY TO TOTAL KNEE REPLACEMENT, THERE WAS AN ISSUE WITH INSTRUMENT TIES USING INTERRUPTED STITCHES. AS A RESULT, THE PATIENT EXPERIENCED WOUND DEHISCENCE. THE PATIENT CAME BACK IN FOR SECOND SURGERY WHICH WAS A WOUND DEBRIDEMENT.

  Patient problems: Wound Dehiscence

  MAUDE report 19596500 ↗
• InjuryJun 24, 2024Unraveled Material; Unraveled Material

  ACCORDING TO THE REPORTER, POST-OPERATIVELY TO TOTAL KNEE REPLACEMENT, THERE WAS AN ISSUE WITH INSTRUMENT TIES USING INTERRUPTED STITCHES. AS A RESULT, THE PATIENT EXPERIENCED WOUND DEHISCENCE. THE PATIENT CAME BACK IN FOR SECOND SURGERY WHICH WAS A WOUND DEBRIDEMENT.

  Patient problems: Wound Dehiscence

  MAUDE report 19596381 ↗
• InjuryJun 24, 2024Unraveled Material; Unraveled Material

  ACCORDING TO THE REPORTER, POST-OPERATIVELY TO TOTAL KNEE REPLACEMENT, THERE WAS AN ISSUE WITH INSTRUMENT TIES USING INTERRUPTED STITCHES. AS A RESULT, THE PATIENT EXPERIENCED WOUND DEHISCENCE. THE PATIENT CAME BACK IN FOR SECOND SURGERY WHICH WAS A WOUND DEBRIDEMENT.

  Patient problems: Wound Dehiscence

  MAUDE report 19596161 ↗
• 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 19590214 ↗
• 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 19590028 ↗
• 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 19587280 ↗
• 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 19586545 ↗
• 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 19586311 ↗
• 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 19584164 ↗
• 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 19584008 ↗
• 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 19583985 ↗
• 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 19583971 ↗
• 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 19575378 ↗
• 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 19575348 ↗
• InjuryJun 18, 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 19563939 ↗
• InjuryJun 4, 2024Material Frayed; Unraveled Material; Material Frayed; Unraveled Material

  ACCORDING TO THE REPORTER, DURING AN OPEN TOTAL HIP RECONSTRUCTION, WHILE CLOSING THE FASCIA WITH INSTRUMENT TIE SUTURING TECHNIQUE, THE SUTURE KNOTS UNRAVEL AND DID NOT HOLD. IT WAS REPORTED THAT THE EVENT LED TO EXTENDED PATIENT HOSPITALIZATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19461683 ↗
• InjuryJun 3, 2024Material Frayed; Unraveled Material; Material Frayed; Unraveled Material

  ACCORDING TO THE REPORTER, DURING AN OPEN TOTAL HIP RECONSTRUCTION, WHILE CLOSING THE FASCIA WITH INSTRUMENT TIE SUTURING TECHNIQUE, THE SUTURE KNOTS UNRAVEL AND DID NOT HOLD. IT WAS REPORTED THAT THE EVENT LED TO EXTENDED PATIENT HOSPITALIZATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19447679 ↗
• InjuryJan 9, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, THE PATIENT HAD A POST-OPERATIVE COMPLICATION AFTER A HIP REPLACEMENT ARTHROPLASTY PROCEDURE.

  Patient problems: Injury

  MAUDE report 9568983 ↗
• InjuryJan 3, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, A MONTH FOLLOWING AN OPEN HIP REPLACEMENT ARTHROPLASTY, IT WAS STATED THAT ON THE (B)(6), PATIENT WAS PRESENTED WITH DRAINING HEMATOMA. A REVISION OF RIGHT HIP WITH IRRIGATION DEBRIDEMENT BALL AND LINER EXCHANGE PERFORMED TO CORRECT THE ISSUE.

  Patient problems: Hematoma; No Code Available

  MAUDE report 9548174 ↗

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-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-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-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-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-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