Tacker OMS-TTHRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10884521070455), received between Apr 19, 2018 and Apr 19, 2018 — classified as 1 malfunction.

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

2 other recalls cover devices cleared under the same FDA submission (K090470); 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 16, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 19, 2018Break; Break

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE DEVICE'S HOLDER WAS FOUND TORN IN THE MIDDLE UPON OPENING THE PACKAGE. THE CUSTOMER INDICATED NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 7443773 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K090470. One submission often covers many models, so check the product and lot details in each record.

• Z-0986-2024 · Nov 16, 2023 · Open, Classified
  AbsorbaTack Absorbable Fixation Device 30 Violet Absorbable Tacks 5 mm- -intended for fixation of prosthetic material to soft tissue in minimally invasive and open surgical hernia
• Z-1157-2010 · Feb 8, 2010 · Terminated
  Auto Suture ProTack Fixation 5 mm Product Catalogue # 174006. Has application in endoscopic surgery procedures.