COMPREHENSIVE 405807Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00880304532366), received between Dec 5, 2019 and Sep 10, 2026 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Naturally Worn” (3 reports).

4 other recalls cover devices cleared under the same FDA submission (K120121); 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 10, 2026Naturally Worn

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50722751 ↗
• MalfunctionSep 10, 2026Naturally Worn

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50722743 ↗
• MalfunctionSep 10, 2026Naturally Worn

  It was reported that the reamers were dull. There was no patient involvement. Attempts have been made and no further information has been provided.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50715878 ↗
• InjuryDec 5, 2019Off-Label Use; Off-Label Use

  NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: No Code Available

  MAUDE report 9416235 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K120121. One submission often covers many models, so check the product and lot details in each record.

• Z-0093-2021 · Sep 2, 2020 · Terminated
  Biomet Comprehensive Reverse Shoulder Glenosphere Mini Baseplate with Taper Adapter-Shoulder Prosthesis item: 010000589 - Product Usage: intended to serve as the foundation for th
• Z-1615-2020 · Feb 25, 2020 · Terminated
  Biomet Comprehensive Reverse Shoulder Glenosphere Mini Baseplate With Taper Adapter-indicated for primary, fracture, or revision total shoulder replacement for the relief of pain a
• Z-0972-2019 · Dec 21, 2018 · Terminated
  Comprehensive Reverse Shoulder System Glenosphere Mini Baseplate with Taper Adapter, Model Number 010000589 Biomet Comprehensive Reverse Shoulder products are indicated for use
• Z-1208-2015 · Jan 7, 2015 · Terminated
  Comprehensive Reverse Shoulder Glenosphere Mini Baseplate 25mm with Taper Adaptor, Part Number: 010000589 Lot: 527400