C7 3-0 Pl Gut 27"/70cm 553BRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00848782009152), received between Jan 11, 2023 and Jan 11, 2023 — classified as 2 injuries.

The most frequently reported specific device problem is “Product Quality Problem” (2 reports).

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

• InjuryJan 11, 2023Product Quality Problem

  THE DISTRIBUTOR REPORTED FOR THE END USER, THE SUTURES USED ARE NOT LASTING VERY LONG THEREFORE PATIENT(S) WOUNDS ARE OPENING AS A RESULT. THE CUSTOMER COMPLETED A QUESTIONNAIRE TO OBTAIN ADDITIONAL DETAILS OF THE EVENT. A 47 YEAR OLD MALE PATIENT RETURNED ON (B)(6) 2022 FOR RE-SUTURE OF AN OPENED INCISION (WITHIN 2 DAYS OF SURGERY). THE PATIENT ''S INCISION WAS RE-SUTURED AND WAS REPORTED IN STABLE CONDITION. THE DOCTOR NOTED, THE PATIENT FOLLOWED ALL POST-OPERATIVE INSTRUCTIONS. NO EVENTS OCCURRED THAT COULD HAVE AFFECTED THE ABSORPTION RATE OR EFFECTIVENESS OF THE SUTURE. NO DEFECTS OR ABNORMALITIES WERE OBSERVED ON THE PACKAGES OR TO THE DEVICES PRIOR TO USE.

  Patient problems: Wound Dehiscence

  MAUDE report 16141294 ↗
• InjuryJan 11, 2023Product Quality Problem

  THE DISTRIBUTOR REPORTED FOR THE END USER, THE SUTURES USED ARE NOT LASTING VERY LONG THEREFORE PATIENT(S) WOUNDS ARE OPENING AS A RESULT. THE CUSTOMER COMPLETED A QUESTIONNAIRE TO OBTAIN ADDITIONAL DETAILS OF THE EVENT. A 69-YEAR-OLD MALE PATIENT RETURNED ON (B)(6) 2022, FOR RE-SUTURE OF AN OPENED INCISION. THE PATIENT ''S INCISION WAS RE-SUTURED AND WAS REPORTED IN STABLE CONDITION. THE DOCTOR NOTED, THE PATIENT FOLLOWED ALL POST-OPERATIVE INSTRUCTIONS. NO EVENTS OCCURRED THAT COULD HAVE AFFECTED THE ABSORPTION RATE OR EFFECTIVENESS OF THE SUTURE. NO DEFECTS OR ABNORMALITIES WERE OBSERVED ON THE PACKAGES OR TO THE DEVICES PRIOR TO USE.

  Patient problems: Wound Dehiscence

  MAUDE report 16138308 ↗