Ti-Cron 88863147-83Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00884521060343), received between Oct 6, 2016 and Oct 14, 2020 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Break” (2 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Dec 21, 2023Class IIOpen, Classified

   Specific lots of sutures were sterilized with gamma doses that exceeded the range approved. The extra gamma levels may decrease the strength of the sutures over time, which could result in harms such as wound dehiscence and hemorrhage/blood loss/ bleeding at a critical level.

   Z-0845-2024 · Root cause: Process control · Recall details · FDA record ↗

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 14, 2020Break; Break

  ACCORDING TO THE REPORTER, DURING PROCEDURE, THE NEEDLE OF THE REPORTED DEVICES BROKE. NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10676744 ↗
• MalfunctionFeb 14, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A TOTAL KNEE PROCEDURE, THE SUTURE BROKE AT THE END WHEN INSTRUMENT TYING. IT WAS STATED THAT THE BREAK OCCURRED IN THE INSTRUMENT AND NOT IN THE KNOT. THE CASE WAS COMPLETED USING THE DEVICE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient; No Information

  MAUDE report 9712581 ↗
• MalfunctionFeb 10, 2020Break; Break

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE THREAD OF THE DEVICE BROKE WHILE THE SURGEON WAS TYING THE KNOT. SURGEON REMOVED THE BROKEN THREAD OUT OF THE TENDON AND CONTINUED WITH A NEW THREAD. NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9686681 ↗
• MalfunctionOct 6, 2016Component Missing; Component Missing

  ACCORDING TO THE REPORTER, THE BOX RECEIVED HAD 4 NEEDLES INSTEAD OF 5. NO PATIENT INVOLVEMENT. TO CORRECT THIS, THEY USED A NEW PACK.

  Patient problems: No Patient Involvement

  MAUDE report 6003980 ↗

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-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-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-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