COMPREHENSIVE 405809Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00880304532298), received between Sep 4, 2019 and Sep 29, 2026 — classified as 4 malfunctions.

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

6 other recalls cover devices cleared under the same FDA submission (K120121, K132239, K193373); 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 29, 2026Fracture

  It was reported that the impactor pad broke off while the baseplate was being impacted. There was no patient impact.It was reported that no further information is available.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50933473 ↗
• MalfunctionMar 10, 2020Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT DURING A PROCEDURE THE BASE OF THE IMPACTOR BROKE OFF. NO CONSEQUENCES OR IMPACT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9812619 ↗
• MalfunctionDec 20, 2019Fracture; Fracture

  IT WAS REPORTED THE INSTRUMENT FRACTURED DURING USE WITH NO ADVERSE CONSEQUENCE TO THE PATIENT OR PROCEDURE. NO FURTHER INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORTING.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9501524 ↗
• MalfunctionSep 4, 2019Fracture; Fracture

  IT WAS REPORTED THE INSTRUMENT FRACTURED DURING USE. NO PATIENT HARM REPORTED PER SURGEON. NO FURTHER INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORTING.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8959968 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K120121, K132239, K193373. One submission often covers many models, so check the product and lot details in each record.

• Z-1131-2021 · Jan 15, 2021 · Terminated
  Central Screw 6.5x25mm - Product Usage: used as a sterile screw that is intended for implantable shoulder prosthesis assembly and/or fixation.
• Z-0619-2021 · Nov 25, 2020 · Terminated
  Comprehensive Reverse Shoulder System, Item numbers 115394, 115395, 115396, 115398, 180550, 180551, 180552, 180553, 180554, 180555, 180556, 180557, 180558, 180559, 180560, 180562
• 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