V-Loc 90 VLOCM0034Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 10884521131729), received between Aug 28, 2017 and Oct 19, 2025 — classified as 2 injuries, 16 malfunctions.

The most frequently reported specific device problem is “Break” (8 reports).

1 other recall cover devices cleared under the same FDA submission (K100257); 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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• InjuryOct 19, 2025Unraveled Material; Unraveled Material

  IT WAS REPORTED THAT 4 TO 5 WEEKS FOLLOWING AN OPEN TOTAL KNEE ARTHROPLASTY WHERE THREE SUTURES WERE USED, DEHISCENCE OF ALL TISSUE LAYERS THAT WERE SUTURED OCCURRED AFTER A FALL. ADDITIONAL SURGERY WAS REQUIRED AS AN INTERVENTION. IT WAS NOTED THAT THE SURGEON USED ANOTHER SUTURE FROM ANOTHER COMPANY.

  Patient problems: Wound Dehiscence

  MAUDE report 23334119 ↗
• InjuryOct 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT FOLLOWING A TOTAL KNEE ARTHROPLASTY, DEHISCENCE OF ALL TISSUE LAYERS EXCEPT THE FASCIA OCCURRED POST-OPERATIVELY. THIS RAISES CONCERNS ABOUT THE DEVICE'S STRENGTH AT FOUR WEEKS COMPARED TO OTHER MANUFACTURING SUTURES. TWO SUTURES WERE USED, WHILE THE FASCIA WAS CLOSED WITH A DIFFERENT TYPE OF SUTURE. THE DEHISCENCE WAS ATTRIBUTED TO A FALL EXPERIENCED BY THE PATIENT AFTER SURGERY. ADDITIONAL SURGERY WAS REQUIRED, AND AN OPEN PROCEDURE WAS PERFORMED TO ADDRESS THE DEHISCENCE.

  Patient problems: Wound Dehiscence

  MAUDE report 23285623 ↗
• MalfunctionSep 13, 2025Unraveled Material; Unraveled Material

  IT WAS REPORTED THAT APPROXIMATELY ONE WEEK FOLLOWING A PANNICULECTOMY, DEHISCENCE OCCURRED.

  Patient problems: Wound Dehiscence

  MAUDE report 23045919 ↗
• MalfunctionJul 28, 2025Break; Material Frayed; Break; Material Frayed

  IT WAS REPORTED THAT DURING AN OPEN PANNICULECTOMY PROCEDURE, SPECIFICALLY AT THE RUNNING DEEP DERMAL SUTURE STEP, THE FIRST SUTURE BROKE IN THE MIDDLE WHILE SUTURING, AND BARBS WERE OBSERVED FRAYING OFF. MOREOVER, ANOTHER TWO SUTURES BROKE IN THE MIDDLE WHILE SUTURING. TO RESOLVE THE ISSUE, THE COMPETITOR'S SUTURE WAS USED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22637021 ↗
• MalfunctionOct 8, 2024Break; Break

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, WHILE SUTURING, THREE SUTURES BROKE IN THE MIDDLE. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20403353 ↗
• MalfunctionOct 8, 2024Break; Break

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, WHILE SUTURING, THREE SUTURES BROKE IN THE MIDDLE. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20403082 ↗
• MalfunctionOct 8, 2024Break; Break

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, WHILE SUTURING, THREE SUTURES BROKE IN THE MIDDLE. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20402907 ↗
• MalfunctionSep 23, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THERE WAS A NEEDLE DETACHMENT. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20286516 ↗
• MalfunctionSep 23, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A HYSTERECTOMY PROCEDURE, THERE WAS A NEEDLE DETACHMENT. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20282594 ↗
• MalfunctionJan 5, 2024Break; Break

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, WHILE CLOSING AT THE END, THE THREAD BROKE. AN ADDITIONAL NEW DEVICE OF THE SAME TYPE WAS THEN USED.

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

  MAUDE report 18453895 ↗
• MalfunctionJun 30, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, PRIOR TO A PRIOR TO A PROCEDURE, WHEN THE SUTURE WAS BEING PULLED OUT OF THE PACKAGE THE NEEDLE OF THE SUTURE DETACHED. FIVE SUTURES WERE AFFECTED OF THIS ISSUE DURING THE SAME EVENT. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17238241 ↗
• MalfunctionOct 27, 2021Break; Break

  ACCORDING TO THE REPORTER, DURING KNEE SURGERY, THE THREAD BROKE. ADDITIONAL SUTURE WAS USED TO CONTINUE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12707597 ↗
• MalfunctionJul 14, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER DURING AN OPEN DERMOLIPECTOMY PROCEDURE, WHEN CLOSING THE TISSUE DURING THE FIRST AND SECOND SUTURE, BOTH THREAD CAME LOOSE FROM THE NEEDLE. TO FIX THE ISSUE A NEW SUTURE WAS USED BY THE SURGEON TO FINISHED THE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12167208 ↗
• MalfunctionOct 31, 2020Break; Break

  ACCORDING TO THE REPORTER, DURING OPEN BREAST PLASTIC PROCEDURE, SUTURE BROKE. A NEW SUTURE FROM THE SAME PACKAGE WAS USED TO COMPLETE THE SURGERY. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10767337 ↗
• MalfunctionDec 26, 2019Break; Break

  ACCORDING TO THE REPORTER, DURING TOTAL KNEE REPLACEMENT, TWO THREADS BROKE WHEN LOOP WAS BEING CINCHED DOWN. ANOTHER PACKAGE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9519753 ↗
• MalfunctionDec 28, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING AN OPEN PROCEDURE, WHILE SUTURING, THE NEEDLE POPPED OFF PREMATURELY. ANOTHER SUTURE WAS OPENED AND USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8202595 ↗
• MalfunctionSep 5, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, WHILE BEING TAKEN OUT OF THE PACKAGE AND LOADED DURING AN OPEN DIEP FLAP, THE NEEDLE PULLED APART FROM THE THREAD AND BOTH WERE BROKEN. THEY USED DIFFERENT PRODUCT TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7847812 ↗
• MalfunctionAug 28, 2017Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER: OCCURRED DURING A LYMPH NODE BIOPSY PROCEDURE. THE NEEDLE POPPED OFF WHEN SUTURING. THERE WAS NO PATIENT HARM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6824969 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K100257. One submission often covers many models, so check the product and lot details in each record.

• Z-2918-2026 · Jun 24, 2026 · Open, Classified
  V-Loc 90 Absorbable Wound Closure Device VLOC 90 0 VL 22 GS-21 VLOCM0336 VLOC 90 0 VL 22 GS-25 VLOCM0436 VLOCM0436 VLOCM0003 V-LOC* 90 4-0 CLR 15CM P12X12 VLOCM0003 VL