POLARSTEM 75018405Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07611996103427), received between Nov 4, 2022 and Nov 4, 2022 — classified as 1 malfunction.

The most frequently reported specific device problem is “Delivered as Unsterile Product” (1 report).

1 other recall cover devices cleared under the same FDA submission (K143739); 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. How this data works · Data updated Oct 13, 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.

• MalfunctionNov 4, 2022Delivered as Unsterile Product; Packaging Problem; Delivered as Unsterile Product; Packaging Problem

  IT WAS REPORTED THAT, A POLARSTEM COLLAR STD. TI/HA 5 WAS RECEIPT AND IT WAS NOTICED THAT THE OUTER PACKAGING WAS INTACT BUT INSIDE WAS NOT SEALED AND PRODUCT WAS DAMAGED. AS THIS WAS NOTICE IN A FIELD INSPECTION, NO PATIENT WAS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15726583 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K143739. One submission often covers many models, so check the product and lot details in each record.

• Z-2827-2020 · Jul 22, 2020 · Open, Classified
  POLARSTEM COLLAR Reamer Guide, Catalog Number: 75102205, UPC Codes: 00885556535493 - Product Usage: Once the appropriate trial rasp size is in place, the adapter is removed and the