COMPREHENSIVE INSTRUMENTATION 110029136Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00880304731523), received between Jul 8, 2022 and Jan 26, 2026 — classified as 15 malfunctions.

The most frequently reported specific device problem is “Naturally Worn” (13 reports).

5 other recalls cover devices cleared under the same FDA submission (K120121, 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 16, 2026.

Most reported problems

Recent adverse event reports

The 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 26, 2026Naturally Worn

  IT WAS REPORTED THAT THE REAMER BLADES WERE DULL, AND THERE WERE NO OTHER COMPLICATIONS DURING SURGERY. MORE EFFORT WAS PUT INTO REAMING DUE TO DULL BLADES. NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24176430 ↗
• MalfunctionOct 16, 2025Naturally Worn; Naturally Worn

  IT WAS REPORTED THE GLENOID REAMER WAS NOT SHARP. NO COMPLICATIONS, INJURIES, OR SURGICAL INTERVENTIONS WERE REPORTED, AND NO FOREIGN BODIES WERE RETAINED DUE TO THIS MALFUNCTION. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23311147 ↗
• MalfunctionAug 18, 2025Naturally Worn; Naturally Worn

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22828359 ↗
• MalfunctionFeb 6, 2025Naturally Worn; Naturally Worn

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21324749 ↗
• MalfunctionJan 13, 2025Naturally Worn; Naturally Worn

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21137887 ↗
• MalfunctionDec 9, 2024Naturally Worn; Naturally Worn

  NO ADDITIONAL INFORMATION IS AVAILABLE REGARDING THE INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20878641 ↗
• MalfunctionJul 17, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT REAMER WAS DULL AND WOULD NOT REAM INTO BONE DURING A PROCEDURE. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19760778 ↗
• MalfunctionDec 4, 2023Naturally Worn; Naturally Worn

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18257411 ↗
• MalfunctionSep 26, 2023Fracture; Fracture

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17816724 ↗
• MalfunctionJul 31, 2023Dull, Blunt; Naturally Worn; Dull, Blunt; Naturally Worn

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17423546 ↗
• MalfunctionApr 11, 2023Naturally Worn; Naturally Worn

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16714451 ↗
• MalfunctionApr 6, 2023Dull, Blunt; Dull, Blunt

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16692623 ↗
• MalfunctionMar 29, 2023Naturally Worn; Naturally Worn

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16635600 ↗
• MalfunctionMar 29, 2023Naturally Worn; Naturally Worn

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16635598 ↗
• MalfunctionJul 8, 2022Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THE INSTRUMENT WAS FOUND TO BE WORN. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14955972 ↗

Recalls under the same FDA submission

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

• 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, 1805
• 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 t
• 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 i
• Z-1208-2015 · Jan 7, 2015 · Terminated
  Comprehensive Reverse Shoulder Glenosphere Mini Baseplate 25mm with Taper Adaptor, Part Number: 010000589 Lot: 527400