V-Loc 90 VLOCM0024Recalls & reported problems

Summary

The FDA's MAUDE database contains 67 adverse event reports that list this exact device (DI 10884521131699), received between Oct 2, 2017 and May 28, 2026 — classified as 1 injury, 66 malfunctions.

The most frequently reported specific device problem is “Break” (49 reports).

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

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. Jun 24, 2026Class IIOpen, Classified

   Product may contain a perforation or tear in the sterile barrier packaging. This issue may result in biocontamination of the sterile sutures, which may lead to infection, loss of vision if in ophthalmic utilization, or prolonged surgery.

   Z-2918-2026 · Root cause: Equipment maintenance · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 67 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 28, 2026Unraveled Material

  IT WAS REPORTED THAT DURING A SUBCUTICULAR CLOSURE OF THE BUTTOCKS, THE BARBS WERE NOT PROMINENT, THE SUTURE WAS NOT HOLDING, AND THERE WAS NOTICEABLE FRAGILITY. IT WAS REPORTED THAT THE PATIENT EXPERIENCED WOUND DEHISCENCE. THE PRODUCT WAS REPORTED AS EXPLANTED.

  Patient problems: Insufficient Information; Wound Dehiscence

  MAUDE report 25317852 ↗
• MalfunctionMay 19, 2026Unraveled Material

  IT WAS REPORTED THAT DURING A SUBCUTICULAR CLOSURE OF THE BUTTOCKS THE BARBS WERE NOT PROMINENT, THE SUTURE WAS NOT HOLDING, AND THERE WAS NOTICEABLE OR VISIBLE FRAGILITY. IT WAS REPORTED THAT THE PATIENT WAS IMPACTED WITH WOUND DEHISCENCE.THE PRODUCT WAS REPORTED AS EXPLANTED.

  Patient problems: Insufficient Information; Wound Dehiscence

  MAUDE report 25216190 ↗
• MalfunctionMar 31, 2026Break

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY OF AN OPEN BONE TUMOR SURGERY, THE THREAD OF TWO SUTURES BROKE IMMEDIATELY DURING SKIN SUTURING. ANOTHER SUTURE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24738536 ↗
• MalfunctionMar 31, 2026Break

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY OF AN OPEN BONE TUMOR SURGERY, THE THREAD OF TWO SUTURES BROKE IMMEDIATELY DURING SKIN SUTURING. ANOTHER SUTURE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24738530 ↗
• MalfunctionJan 29, 2026Break

  IT WAS REPORTED THAT DURING AN OPEN SOFT TISSUE SARCOMA EXCISION PROCEDURE, IN SKIN SUTURING, WHILE EMPLOYING A CONTINUOUS SUTURING TECHNIQUE, THE TAIL RING OF THE DEVICE BROKE INSTANTLY. TO RESOLVE THE ISSUE, A NEW SUTURE WAS USED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24217380 ↗
• MalfunctionJan 20, 2026Break

  IT WAS REPORTED THAT DURING AN OPEN REDUCTION INTERNAL FIXATION, WHILE SUTURING, THE SUTURE BROKE IN THE MIDDLE. AN ADDITIONAL NEW SUTURE WAS USED WITHOUT ISSUE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24122573 ↗
• MalfunctionDec 8, 2025Break; Dull, Blunt; Break; Dull, Blunt

  IT WAS REPORTED THAT DURING AN OPEN LAMINECTOMY, WHEN CLOSING THE SKIN, WHILE SUTURING THE LOOP BROKE, AND THE NEEDLE WAS NOTED TO DULL QUICKLY. THE PHYSICIAN REPORTED GRABBING THE NEEDLE TIP WHEN PULLING IT THROUGH THE SKIN. A NEW SUTURE WAS USED WITHOUT ISSUE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23736104 ↗
• MalfunctionDec 5, 2025Break; Break

  ACCORDING TO THE REPORTER, THE SUTURE BROKE.

  Patient problems: Insufficient Information

  MAUDE report 23728113 ↗
• MalfunctionDec 5, 2025Break; Dull, Blunt; Break; Dull, Blunt

  IT WAS REPORTED THAT DURING SKIN CLOSURE IN AN OPEN LAMINECTOMY PROCEDURE, THE NEEDLE BECAME DULL DURING USE. THE STRAND AND THE LOOP BROKE AS THE SUTURE WAS BEING ANCHORED. IT WAS NOTED THAT THE PHYSICIAN WAS GRABBING THE NEEDLE BY THE POINT TO PULL IT THROUGH THE SKIN, AND A NURSE MENTIONED THAT THE PHYSICIAN WAS VERY ROUGH ON THE SUTURE. AN ADDITIONAL NEW SUTURE WAS USED WITHOUT ISSUE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23727952 ↗
• MalfunctionDec 4, 2025Break; Break

  IT WAS REPORTED THAT DURING AN OPEN SHOULDER PROCEDURE, WHILE CLOSING THE SKIN, DURING SUTURING, THE LOOP OF THE SUTURE BROKE. AFTER THE FIRST LOOP BROKE, ANOTHER BARBED SUTURE WAS OPENED, AND THE LOOP BROKE AGAIN; SUBSEQUENTLY, A COMPETITOR'S SUTURE WAS USED TO RESOLVE THE ISSUE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23717906 ↗
• MalfunctionDec 4, 2025Break; Break

  IT WAS REPORTED THAT DURING AN OPEN SHOULDER PROCEDURE, WHILE CLOSING THE SKIN, DURING SUTURING, THE LOOP OF THE SUTURE BROKE. AFTER THE FIRST LOOP BROKE, ANOTHER BARBED SUTURE WAS OPENED, AND THE LOOP BROKE AGAIN; SUBSEQUENTLY, A COMPETITOR'S SUTURE WAS USED TO RESOLVE THE ISSUE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23717890 ↗
• MalfunctionNov 24, 2025Break; Break

  IT WAS REPORTED THAT DURING AN OPEN BONE TUMOR SURGERY, AT THE SKIN SUTURING STEP, THREE ABSORBABLE SUTURES WERE FOUND TO BE DEFECTIVE IN SUCCESSION. THE FIRST PACK EXHIBITED A CRACKED TAIL LOOP AFTER THE FIRST STITCH, THE SECOND PACK HAD THE NEEDLE AND THREAD DETACH, AND THE THIRD PACK EXPERIENCED THREAD BREAKAGE. ALL ISSUES OCCURRED WITHIN LESS THAN FIVE MINUTES OF USE AND DURING INTRADERMAL CONTINUOUS SUTURING. THE DEFECTIVE SUTURES WERE REPLACED WITH REGULAR ABSORBABLE THREAD FROM ANOTHER MANUFACTURER TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23633642 ↗
• MalfunctionNov 24, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN OPEN BONE TUMOR SURGERY, AT THE SKIN SUTURING STEP, THREE ABSORBABLE SUTURES WERE FOUND TO BE DEFECTIVE IN SUCCESSION. THE FIRST PACK EXHIBITED A CRACKED TAIL LOOP AFTER THE FIRST STITCH, THE SECOND PACK HAD THE NEEDLE AND THREAD DETACH, AND THE THIRD PACK EXPERIENCED THREAD BREAKAGE. ALL ISSUES OCCURRED WITHIN LESS THAN FIVE MINUTES OF USE AND DURING INTRADERMAL CONTINUOUS SUTURING. THE DEFECTIVE SUTURES WERE REPLACED WITH REGULAR ABSORBABLE THREAD FROM ANOTHER MANUFACTURER TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23633444 ↗
• MalfunctionNov 24, 2025Break; Break

  IT WAS REPORTED THAT DURING AN OPEN BONE TUMOR SURGERY, AT THE SKIN SUTURING STEP, THREE ABSORBABLE SUTURES WERE FOUND TO BE DEFECTIVE IN SUCCESSION. THE FIRST PACK EXHIBITED A CRACKED TAIL LOOP AFTER THE FIRST STITCH, THE SECOND PACK HAD THE NEEDLE AND THREAD DETACH, AND THE THIRD PACK EXPERIENCED THREAD BREAKAGE. ALL ISSUES OCCURRED WITHIN LESS THAN FIVE MINUTES OF USE AND DURING INTRADERMAL CONTINUOUS SUTURING. THE DEFECTIVE SUTURES WERE REPLACED WITH REGULAR ABSORBABLE THREAD FROM ANOTHER MANUFACTURER TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23633394 ↗
• MalfunctionNov 14, 2025Break; Break

  ACCORDING TO THE REPORTER, DURING A HIP REPLACEMENT SURGERY, IN CLOSING THE DERMIS, THE CENTER PART OF THE SUTURE WAS DAMAGED WHILE SUTURING. TO RESOLVE THE ISSUE, A NEW DEVICE WAS USED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23560853 ↗
• MalfunctionNov 12, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN OPEN LIVER RESECTION, THE SUTURE WAS APPLIED FOR ABDOMINAL CLOSURE USING A CONTINUOUS SUTURING TECHNIQUE, AND THE THREAD BROKE LESS THAN FIVE MINUTES INTO THE PROCEDURE. ADDITIONALLY, DURING THE SAME PROCEDURE, ANOTHER SUTURE WAS USED FOR CONTINUOUS INTRADERMAL SUTURING, AND BOTH THE NEEDLE AND THREAD BROKE LESS THAN FIVE MINUTES INTO THE PROCEDURE. THE SUTURES WERE REPLACED WITH NEW SUTURES, AND THE PROCEDURE WAS COMPLETED WITHOUT FURTHER ISSUE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23532095 ↗
• MalfunctionSep 19, 2025Break; Break

  ACCORDING TO THE REPORTER, THE SUTURE BROKE WHILE SUTURING.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 23096110 ↗
• MalfunctionAug 13, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A PROCEDURE, THE NEEDLE AND THREAD OF THE TWO SUTURES DETACHED WHEN THE SURGEON STARTED SUTURING. TO RESOLVE THE ISSUE, A NEW DEVICE FROM ANOTHER MANUFACTURER WAS USED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22798143 ↗
• MalfunctionAug 13, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A PROCEDURE, THE NEEDLE AND THREAD OF THE TWO SUTURES DETACHED WHEN THE SURGEON STARTED SUTURING. TO RESOLVE THE ISSUE, A NEW DEVICE FROM ANOTHER MANUFACTURER WAS USED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22798049 ↗
• MalfunctionJul 17, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A PLASTIC BREAST CASE, THE SUTURE BROKE OFF FROM THE NEEDLE. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS A 20-MINUTE DELAY TO GET A NEW SUTURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22535905 ↗
• MalfunctionMar 10, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A BONE TUMOR SURGERY, DURING AN INTRADERMAL CONTINUOUS SKIN SUTURING, BOTH NEEDLE AND THREAD BROKE. ANOTHER SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21561504 ↗
• MalfunctionOct 23, 2024Break; Break

  ACCORDING TO THE REPORTER, DURING A MASTOPEXY PROCEDURE, ON FOUR DEVICES, WHILE SUTURING, THE THREAD BREAKS IN THE MIDDLE. TO RESOLVE THE ISSUE, ANOTHER BOX OF DEVICES WAS USED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20519368 ↗
• MalfunctionOct 23, 2024Break; Break

  ACCORDING TO THE REPORTER, DURING A MASTOPEXY PROCEDURE, ON FOUR DEVICES, WHILE SUTURING, THE THREAD BREAKS IN THE MIDDLE. TO RESOLVE THE ISSUE, ANOTHER BOX OF DEVICES WAS USED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20519366 ↗
• MalfunctionOct 23, 2024Break; Break

  ACCORDING TO THE REPORTER, DURING A MASTOPEXY PROCEDURE, ON FOUR DEVICES, WHILE SUTURING, THE THREAD BREAKS IN THE MIDDLE. TO RESOLVE THE ISSUE, ANOTHER BOX OF DEVICES WAS USED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20518941 ↗
• MalfunctionOct 23, 2024Break; Break

  ACCORDING TO THE REPORTER, DURING A MASTOPEXY PROCEDURE, ON FOUR DEVICES, WHILE SUTURING, THE THREAD BREAKS IN THE MIDDLE. TO RESOLVE THE ISSUE, ANOTHER BOX OF DEVICES WAS USED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20518734 ↗