SMARTSTITCH M-CONNECTOR OM-8007Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00817470005714), received between Oct 25, 2018 and Oct 25, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (1 report).

1 other recall cover devices cleared under the same FDA submission (K123268); 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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 25, 2018Detachment of Device or Device Component

  IT WAS REPORTED THAT ITEM WAS BEING USED AND AS THE JAW WAS BEING CLOSED, THE ITEM CAME AWAY. NO PATIENT INJURIES REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8005197 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K123268. One submission often covers many models, so check the product and lot details in each record.

• Z-3000-2020 · Feb 21, 2019 · Terminated
  Smith&Nephew SmartStitch PerfectPasser Connector, REF # OM-8010, Rx Only, CE 0123, UDI: 00817470006971