V-Loc 180 VLOCL0114Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10884521130494), received between Sep 20, 2017 and Jan 27, 2022 — classified as 11 malfunctions.

The most frequently reported specific device problem is “Break” (10 reports).

1 other recall cover devices cleared under the same FDA submission (K091087); 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 27, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, PRIOR TO A PROCEDURE, THE NEEDLE AND SUTURE WERE SEPARATED WHEN THE PRODUCT WAS TAKEN OUT FROM THE PACKAGE BY A SCRUB NURSE DUE TO DERMAL SUTURES, SO IT COULD NOT BE USED. THE PHYSICIAN HAS REQUESTED A NEW SERIAL NUMBER BOX WAS OPENED AND THE SURGERY CONTINUED. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13377500 ↗
• MalfunctionMar 6, 2018Break; Break

  ACCORDING TO THE REPORTER, DURING SUBCUTANEOUS SUTURE, THE SUTURE BROKE. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THE PATIENT STATUS IS ALIVE WITH NO INJURY AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7316655 ↗
• MalfunctionJan 8, 2018Break; Break

  ACCORDING TO THE REPORTER, DURING A TOTAL HIP REPLACEMENT PROCEDURE, IN THE BEGINNING OF SKIN CLOSURE, THE DEVICE¿S THREAD BROKE, WHEREIN THE ANCHORING LOOP CAME LOOSE AND THE DEVICE COULD NOT BE USED ANYMORE. A NEW DEVICE WAS USED TO CLOSE THE SKIN AND COMPLETE THE PROCEDURE. NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7173305 ↗
• MalfunctionJan 8, 2018Break; Break

  ACCORDING TO THE REPORTER, DURING A TOTAL KNEE REPLACEMENT PROCEDURE, IN THE BEGINNING OF SKIN CLOSURE, THE DEVICE¿S THREAD BROKE, WHEREIN THE ANCHORING LOOP CAME LOOSE AND THE DEVICE COULD NOT BE USED ANYMORE. A NEW DEVICE WAS USED TO CLOSE THE SKIN AND COMPLETE THE PROCEDURE. NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7172556 ↗
• MalfunctionDec 22, 2017Break; Break

  ACCORDING TO THE REPORTER, DURING A TOTAL HIP REPLACEMENT PROCEDURE, WHILE ON THE CLOSURE OF THE SKIN, THE DEVICE¿S THREAD BROKE, WHEREIN JUST AFTER TAKING A FEW "BITES" THE UNIT BROKE VERY EASILY. A NEW DEVICE WAS USED AND FINISHED THE CLOSURE. NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7142930 ↗
• MalfunctionDec 21, 2017Break; Break

  ACCORDING TO THE REPORTER, DURING A TOTAL HIP REPLACEMENT PROCEDURE, WHILE ON THE CLOSURE OF THE SKIN, THE DEVICE¿S THREAD BROKE, WHEREIN JUST AFTER TAKING A FEW "BITES" THE UNIT BROKE VERY EASILY. NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7140565 ↗
• MalfunctionDec 15, 2017Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING AN OPEN PROCEDURE, WHEN THE DEVICE WAS TAKEN OUT OF THE PACKAGE THE STRAND CAME LOOSE FROM THE NEEDLE. THE NEEDLE AND THE THREAD BROKE. ANOTHER DEVICE OF THE SAME LOT NUMBER WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7122866 ↗
• MalfunctionDec 6, 2017Break; Break

  ACCORDING TO THE REPORTER, DURING THE PROCEDURE, THE DEVICE'S THREAD WAS BROKEN AT THE LOOP. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THE PATIENT WAS ALIVE WITH NO INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7089546 ↗
• MalfunctionOct 16, 2017Break; Break

  ACCORDING TO THE REPORTER, DURING TOTAL KNEE REPLACEMENT, WHILE ANCHORING THE LITTLE LOOP IN THE BEGINNING OF SKIN CLOSURE THE THREAD WAS BROKEN. THE SEAL OF THE LITTLE LOOP CAME LOOSE AND THEREFORE COULD NOT BE ANCHORED AND USED. THEY TOOK A NEW SUTURE AND CLOSED THE INCISION. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6951473 ↗
• MalfunctionSep 21, 2017Break; Break

  ACCORDING TO THE REPORTER, DURING USE, THE LOOP BROKE EASILY. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THE STATUS OF THE PATIENT IS NO PROBLEM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6883915 ↗
• MalfunctionSep 20, 2017Break; Product Quality Problem; Break; Product Quality Problem

  ACCORDING TO THE REPORTER, DURING SKIN CLOSURE IN AN ORTHOPEDIC PROCEDURE, THE ANCHORING LOOP TO SECURE THE V-LOC DEVICE CAME LOOSE IT LOOKED LIKE IT WASN'T WELDED CORRECTLY AND THEREFORE, ANOTHER DEVICE WAS USED IN ORDER TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6880545 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K091087. One submission often covers many models, so check the product and lot details in each record.

• Z-2919-2026 · Jun 24, 2026 · Open, Classified
  V-Loc 180 Absorbable Wound Closure Device BOX BEDSIDE STAPLING IS KING BOX06614V4 BOX BY PASS FINAL BOX07405V1 BOX BYPASS CARDON BOX01056V2 BOX BYPASS DR LAGAE BOX0