SPEEDSTITCH OM-8087Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00817470001044), received between Sep 10, 2020 and Sep 10, 2020 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Device Markings/Labelling Problem” (2 reports).

1 other recall cover devices cleared under the same FDA submission (K042031); 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 10, 2020Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT WHEN THE PART NUMBER OM-8088 WAS BEING UNPACKING, IT WAS NOTICED THAT THE CONTENT DID NOT CORRESPOND WITH THE LABELING. THE BOX CONTAINED THE FOLLOWING: 2 PIECES OF OM-8085, 2 PIECES OF OM-8087 AND 2 PIECES OF OM-8088, INSTEAD OF 6 PIECES OF OM-8088. IT WAS ALSO REPORTED THAT THE PART NUMBER OM-8087 HAD NOT BEEN IMPORTED TO RUSSIA BEFORE. NO CASE OR PATIENT WAS INVOLVED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Patient Involvement

  MAUDE report 10514035 ↗
• MalfunctionSep 10, 2020Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT WHEN THE PART NUMBER OM-8088 WAS BEING UNPACKING, IT WAS NOTICED THAT THE CONTENT DID NOT CORRESPOND WITH THE LABELING. THE BOX CONTAINED THE FOLLOWING: 2 PIECES OF OM-8085, 2 PIECES OF OM-8087 AND 2 PIECES OF OM-8088, INSTEAD OF 6 PIECES OF OM-8088. IT WAS ALSO REPORTED THAT THE PART NUMBER OM-8087 HAD NOT BEEN IMPORTED TO RUSSIA BEFORE. NO CASE OR PATIENT WAS INVOLVED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Patient Involvement

  MAUDE report 10514010 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K042031. One submission often covers many models, so check the product and lot details in each record.

• Z-0611-2012 · Aug 8, 2011 · Terminated
  OPUS SpeedStitch Product Number OM-8086 is a suture cartridge For use in approximation and/or ligation of soft tissues, including use of allograft tissue for orthopedic surgeries.