POLARCUP 75023347Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07611996112368), received between May 18, 2021 and May 18, 2021 — classified as 1 injury.

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

2 other recalls cover devices cleared under the same FDA submission (K123598); 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.

• InjuryMay 18, 2021Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT, DURING THR SURGERY, THE EDGES OF THE POLARCUP T-HANDLE UNIDIRECTIONAL WORN OUT WHILE UNPLUGGED. NO SIGNIFICANT DELAYS WERE REPORTED AND THE PROCEDURE WAS FINISHED BY CHANGING THE SURGICAL TECHNIQUE. NO PATIENT WAS HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11843366 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K123598. One submission often covers many models, so check the product and lot details in each record.

• Z-0730-2019 · Jan 7, 2019 · Terminated
  SL PLUS MIA DOUBLE OFFSET ADAPTER RIGHT 60/25MM, S&N 75004613
• Z-1008-2017 · Nov 16, 2016 · Terminated
  REFLECTION(R) DEAD BLOW MALLET, REF 71362106, QTY: (1), NON-STERILE, Smith & Nephew, Inc,. Memphis, TN 38116