V-Loc 90 VLOCM3225Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10884521162365), received between May 23, 2018 and Jul 6, 2021 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Break” (9 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 6, 2021Break; Break

  ACCORDING TO THE REPORTER, DURING AN OPEN PROCEDURE ON WOUND CLOSURE, THE STRAND JUST SNAPPED AND IT BROKE HALFWAY THROUGH. EXCESSIVE FORCE WAS NOT USED. ANOTHER SUTURE WAS UTILIZED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12120448 ↗
• MalfunctionJun 11, 2021Break; Dull, Blunt; Material Twisted/Bent; Break; Dull, Blunt; Material Twisted/Bent

  ACCORDING TO THE REPORTER, AFTER THE SECOND PASS WHEN CLOSING AN OPEN TOTAL KNEE REVISION, THE NEEDLE BENT AND BECAME DULL THEN THE SUTURE BROKE. THE MALFUNCTION HAPPENED TWICE. A NEW SUTURE WAS USED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11987658 ↗
• MalfunctionJun 9, 2021Break; Dull, Blunt; Material Twisted/Bent; Break; Dull, Blunt; Material Twisted/Bent

  ACCORDING TO THE REPORTER, DURING AN OPEN TOTAL KNEE REVISION PROCEDURE, AFTER 2ND PASS THE DEVICE'S NEEDLE BECAME DULL AND BENT, THEN SUTURE BROKE. THIS HAPPENED TWICE DURING THE CASE. THE SURGEON THEN USED ANOTHER DEVICE TO RESOLVE THE ISSUE IN ORDER TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11967851 ↗
• MalfunctionNov 16, 2020Break; Break

  ACCORDING TO THE REPORTER, DURING AN ORTHOPEDIC PROCEDURE, THE THREAD OF THE SUTURE WAS BROKEN. THE ISSUE OCCURRED FOR A TOTAL OF FOUR TIMES. THE FIFTH SUTURE WAS USED IN ORDER TO RESOLVE THE ISSUE AND COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10844561 ↗
• MalfunctionAug 17, 2020Break; Break

  ACCORDING TO THE REPORTER, DURING AN OPEN PROCEDURE, WHEN CLOSING HALF WAY THROUGH THE SUTURE BROKE. MULTIPLE SUTURES HAD TO BE USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10414541 ↗
• MalfunctionNov 29, 2018Break; Break

  ACCORDING TO THE REPORTER, DURING AN OPEN ORTHOPEDIC PROCEDURE, THE THREAD OF THE SUTURES BROKE. A NEW ONE WAS OPENED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8114042 ↗
• MalfunctionNov 28, 2018Break; Break

  ACCORDING TO THE REPORTER DURING A ORTHOPEDIC PROCEDURE, 30 MINUTES INTO THE PROCEDURE, WHILE USING A RUNNING TECHNIQUE, THE THREAD OF THE DEVICE BROKE. A NEW SUTURE WAS OPENED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT HARM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8111151 ↗
• MalfunctionAug 23, 2018Break; Break

  ACCORDING TO THE REPORTER, THE THREAD BROKE WHILE SUTURING DURING AN OPEN ORTHOPEDIC. THEY OPENED A NEW ONE TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7809234 ↗
• MalfunctionMay 23, 2018Break; Break

  ACCORDING TO THE REPORTER, DURING CLOSURE IN A TOTAL KNEE REPLACEMENT PROCEDURE, THE THREAD OF THE SUTURE BROKE. THEY REPLACED THE DEVICE WITH A NEW STRAND TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7538681 ↗

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