PDS Z991GRecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10705031061996), received between Jul 22, 2020 and Feb 6, 2025 — classified as 3 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Material Separation” (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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 6, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN EXPLORATORY LAPAROTOMY PROCEDURE ON (B)(6)2025 AND SUTURE WAS USED ON THE FASCIA. DURING THE PROCEDURE, WHILE CLOSING THE FACIA ON AN ABDOMINAL INCISION, THE NEEDLE POPPED OFF THE SUTURE UNEXPECTEDLY. ANOTHER LIKE DEVICE WAS USED TO CONTINUE WITH THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21320916 ↗
• MalfunctionFeb 6, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN EXPLORATORY LAPAROTOMY PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED ON THE FASCIA. DURING THE PROCEDURE, WHILE CLOSING THE FACIA ON AN ABDOMINAL INCISION, THE NEEDLE POPPED OFF THE SUTURE UNEXPECTEDLY. ANOTHER LIKE DEVICE WAS USED TO CONTINUE WITH THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21320912 ↗
• MalfunctionAug 10, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A FACIAL CLOSURE PROCEDURE IN 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED THAT THE NEEDLE TIP HAD BROKEN OFF. SURGEON COMPLETED THE FACIAL CLOSURE THEN TRIED TO FIND THE NEEDLE TIP WITH FLUOROSCOPY. THEY WERE UNABLE TO FIND THE NEEDLE TIP AND THE PATIENT WAS RECOVERED FROM SURGERY.THE NEEDLE DID NOT FALL INTO THE PATIENT. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17504697 ↗
• MalfunctionMay 3, 2023Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT A PATIENT UNDERWENT A SHOULDER ARTHROSCOPY PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, THEY OPENED THE SUTURE AND IT HAD A HAIR IN IT. A NEW SUTURE WAS USED TO COMPLETE THE CASE WITH NO PATIENT CONSEQUENCES. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16862859 ↗
• InjuryDec 8, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2020 AND THE SUTURE WAS USED. POST-OPERATIVELY, THE PATIENT EXPERIENCED COMPLETE WOUND DEHISCENCE OF AN ABDOMINAL INCISION WITH EACH END OF THE FASCIA CLOSURE SECURED WITH A LOOP. EVENT OCCURRED ONE WEEK POST-OPERATIVELY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Wound Dehiscence

  MAUDE report 10972600 ↗
• InjuryDec 8, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2020 AND THE SUTURE WAS USED. POST-OPERATIVELY, THE PATIENT EXPERIENCED COMPLETE WOUND DEHISCENCE OF AN ABDOMINAL INCISION WITH EACH END OF THE FASCIA CLOSURE SECURED WITH A LOOP. EVENT OCCURRED ONE WEEK POST-OPERATIVELY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Wound Dehiscence

  MAUDE report 10972570 ↗
• InjuryJul 22, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN EXPLORATORY COLON SURGERY ON (B)(6) 2020 AND THE SUTURE WAS USED FOR ABDOMINAL CLOSURE. THE PATIENT RETURNED WITH ABDOMINAL DEHISCENCE ON (B)(6) 2020 AND REQUIRED A REPAIR. THE REVISION SURGERY WAS PERFORMED ON (B)(6) 2020. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Not Applicable; Wound Dehiscence

  MAUDE report 10311933 ↗