V-Loc 90 VLOCM0113Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10884521131743), received between Oct 13, 2017 and Jun 2, 2023 — classified as 1 injury, 7 malfunctions.

The most frequently reported specific device problem is “Break” (7 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 2, 2023Break; Break

  ACCORDING TO THE REPORTER, DURING AN ORTHOPEDIC SURGERY FOR A FOOT FRACTURE AS THE DOCTOR WAS PULLING THE NEEDLE OF BOTH DEVICE, THE SUTURE HOLE BROKE. ANOTHER SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17051351 ↗
• InjuryJun 6, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, A FEW DAYS AFTER A SPINAL CORD STIMULATOR PERMANENT IMPLANT PROCEDURE, THE PATIENT INFORMED THE SURGEON THAT THEY ARE EXPERIENCING PAIN FROM THE STITCHES AND IT WAS VERY PAINFUL. THERE WERE NO ISSUES WHEN THE INITIAL PROCEDURE WAS DONE.

  Patient problems: Pain

  MAUDE report 14604874 ↗
• MalfunctionAug 13, 2018Break; Break

  ACCORDING TO THE REPORTER, DURING A SKIN CLOSURE AT THE END OF THE PROCEDURE ON AN OPEN HIP SURGERY, THE THREAD OF THE SUTURE BROKE. A NEW THREAD WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7777173 ↗
• MalfunctionMar 9, 2018Break; Break

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, AT THE BEGINNING OF THE PROCEDURE, THE DEVICE¿S LOOP UNSNAPPED DURING PREPARATION FOR USE. ANOTHER DEVICE WAS USED IN ORDER TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7326910 ↗
• MalfunctionDec 8, 2017Break; Break

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, THE DEVICE HAD LOOP ON END AND HAD OPENED WHILE BEING APPLIED ON SKIN USING THE SUBCUTANEOUS SUTURING TECHNIQUE AT THE END OF THE PROCEDURE. THEY OPENED ANOTHER SUTURE IN ORDER TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7100213 ↗
• MalfunctionOct 18, 2017Break; Break

  ACCORDING TO THE REPORTER, DURING AN ORTHOPEDIC PROCEDURE, THE THREAD OF THE SUTURE BROKE WHILE DOING A RUNNING STITCH. AN ADDITIONAL NEW SUTURE WAS USED WITHOUT ISSUE TO COMPLETE THE CASE. THE PATIENT IS ALIVE WITH NO INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6959691 ↗
• MalfunctionOct 13, 2017Break; Break

  ACCORDING THE REPORTER, THE LOOP KNOT OF THE SUTURE WAS BROKEN. PATIENT INVOLVEMENT WAS UNKNOWN DURING THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6949267 ↗
• MalfunctionOct 13, 2017Break; Break

  ACCORDING THE REPORTER, THE LOOP KNOT OF THE SUTURE WAS BROKEN. PATIENT INVOLVEMENT WAS UNKNOWN DURING THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6949112 ↗

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