Snowden-Pencer 89-6210Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10885403122866), received between May 12, 2021 and May 12, 2021 — classified as 1 malfunction.

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

1 other recall cover devices cleared under the same FDA submission (K092684); 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.

• MalfunctionMay 12, 2021Break; Break

  IT WAS REPORTED THAT THE GUIDING WIRE WAS BROKEN INSIDE THE RETRACTOR AND NOW PROTRUDING OUT OF THE LUMEN. THE BROKEN WIRE DOES NOT ALLOW FOR FULL FUNCTIONALITY OF THE DEVICE. THERE WAS NO PATIENT IMPACT OR INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11814372 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K092684. One submission often covers many models, so check the product and lot details in each record.

• Z-2212-2016 · Jul 1, 2016 · Terminated
  DIAMOND-FLEX CIRCULAR RETRACTOR, ANGLED, 40MM 5MM, Product Code 89-6114, Lot Code(s): 878971; 879366; 879404, and Date Code: C16. Designed to retract or elevate organs and tissue