Ti-Cron 88863047-41Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10884521059283), received between Jun 20, 2019 and Jun 20, 2019 — classified as 2 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 2, 2022Class IIOpen, Classified

   Sterile Barrier Breach of Breather Pouch may cause infection or vision loss for ophthalmic procedures in cases where there is direct patient contact

   Z-1181-2023 · Root cause: Packaging process control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 20, 2019Break; Break

  ACCORDING TO THE REPORTER, DURING A HAND SURGERY, THE SUTURE WAS USED FOR TENDONS. WHILE DOING THE SURGEON'S KNOT TYING AND POSITIONING THE KNOT, THE SURGEON WAS NOT EXERTING FORCE BUT THE SUTURES COMING FROM THE REPORTED BOXES BROKE. NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8717092 ↗
• MalfunctionJun 20, 2019Break; Break

  ACCORDING TO THE REPORTER, DURING A HAND SURGERY, THE SUTURE WAS USED FOR TENDONS. WHILE DOING THE SURGEON'S KNOT TYING AND POSITIONING THE KNOT, THE SURGEON WAS NOT EXERTING FORCE BUT THE SUTURES COMING FROM THE REPORTED BOXES BROKE. NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8717077 ↗

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-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
• 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
• 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