STRATAFIX SXPP1B429Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10705031235816), received between Jun 16, 2021 and Jun 16, 2021 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Positioning Failure” (2 reports).

1 FDA recall record name this device's identifier.

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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Aug 28, 2019Terminated

   The product do not meet certain internal testing specifications.

   Z-1336-2020 · Root cause: Under Investigation by firm · FDA record ↗

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.

• MalfunctionJun 16, 2021Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT A PATIENT UNDERWENT A ROBOTIC HYSTERECTOMY ON (B)(6) 2021 AND A BARBED SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE HAD BARBS THAT WERE ALMOST NONEXISTENT. ANOTHER LIKE DEVICE FROM A DIFFERENT LOT WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12009705 ↗
• MalfunctionJun 16, 2021Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT A PATIENT UNDERWENT A ROBOTIC HYSTERECTOMY ON (B)(6) 2021 AND A BARBED SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE HAD BARBS THAT WERE ALMOST NONEXISTENT. ANOTHER LIKE DEVICE FROM A DIFFERENT LOT WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12009696 ↗