V-Loc 90 VLOCM0624Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10884521132627), received between Mar 5, 2019 and Nov 3, 2020 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 3, 2020Break; Break

  ACCORDING TO THE REPORTER, THE DEVICE'S THREAD BROKE.

  Patient problems: No Information

  MAUDE report 10777931 ↗
• MalfunctionMar 5, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, BEFORE USING ON THE PATIENT, THE SUTURE WAS REMOVED FROM THE PACKAGE, BUT THE NEEDLE WAS RELEASED INTO THE SEALED PACKAGE. THE WIRE WAS NOT USED AND WAS REPLACED WITH ANOTHER ONE OF THE SAME CODE AND LOT WITHOUT PROBLEM. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8391947 ↗

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