COMPREHENSIVE INSTRUMENTATION 110028879Recalls & reported problems

Summary

The FDA's MAUDE database contains 71 adverse event reports that list this exact device (DI 00880304731394), received between Mar 16, 2020 and Sep 15, 2026 — classified as 71 malfunctions.

The most frequently reported specific device problem is “Fracture” (70 reports).

20 other recalls cover devices cleared under the same FDA submission (K080642, 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 71 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 15, 2026Fracture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50776287 ↗
• MalfunctionSep 9, 2026Fracture

  It was reported that while loading the glenosphere, the plastic tip of the instrument was discovered to be broken. Another set was opened with no delay or issues. There were no consequences or impact to the patient. Attempts have been made and no further information has been provided.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50691833 ↗
• MalfunctionAug 27, 2026Fracture

  It was reported that the glenosphere inserter pad broke. Attempts have been made and no further information has been provided.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50476951 ↗
• MalfunctionAug 17, 2026Fracture

  It was reported that the tip of a glenosphere impactor fractured during impaction. The event occurred intra-operatively while the surgeon was impacting the glenosphere, and the procedure was completed using a secondary instrument. There were no consequences or impact to the patient. Attempts have been made and no further information has been provided.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50275249 ↗
• MalfunctionJul 31, 2026Fracture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50096885 ↗
• MalfunctionJun 29, 2026Fracture

  IT WAS REPORTED THAT THE TIP OF AN INSERTER BROKE. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25651133 ↗
• MalfunctionJan 21, 2026Fracture

  IT WAS REPORTED THAT THE BLACK PLASTIC PIECE OF A TWO-PRONG INSERTER/IMPACTOR BROKE DURING A PROCEDURE. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24132933 ↗
• MalfunctionJan 14, 2026Fracture

  IT WAS REPORTED THAT THE GLENOSPHERE IMPACTOR TIP BROKE DURING IMPACTION TO THE GLENOSPHERE. THE CORRECT SURGICAL TECHNIQUE WAS USED. THE SURGERY WAS COMPLETED USING THE SECONDARY IMPACTOR. THE PIECES DID GO INTO THE PATIENT BUT WERE ALL RETRIEVED AND THEN THROWN AWAY. THIS ITEM HAD BEEN USED IN SURGERY BEFORE. NO COMPLICATIONS, INJURIES, OR SURGICAL INTERVENTIONS WERE REQUIRED, AND NO FOREIGN BODIES WERE RETAINED DUE TO THIS MALFUNCTION. ATTEMPTS HAVE BEEN MADE, AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24069079 ↗
• MalfunctionJan 13, 2026Fracture

  IT WAS REPORTED THAT A PLASTIC COMPONENT WAS FOUND SHATTERED DURING SETUP AND A REPLACEMENT WAS OBTAINED FOR THE CASE. 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 24051114 ↗
• MalfunctionJan 13, 2026Fracture

  IT WAS REPORTED THAT THE PLASTIC CONCAVE TIP FRACTURED INTO TWO PIECES DURING GLENOSPHERE IMPACTION. THE EVENT OCCURRED INTRAOPERATIVELY DURING GLENOSPHERE IMPACTION, AND PROPER SURGICAL TECHNIQUE WAS REPORTED TO HAVE BEEN ADHERED TO. THERE WERE NO CONSEQUENCES OR IMPACT TO THE PATIENT. ATTEMPTS HAVE BEEN MADE, AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24051081 ↗
• MalfunctionDec 19, 2025Fracture; Fracture

  IT WAS REPORTED THAT WHILE IMPACTING THE GLENOSPHERE INTO THE BASEPLATE, THE BLACK TIP BROKE OFF. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23856369 ↗
• MalfunctionDec 15, 2025Fracture; Fracture

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23804214 ↗
• MalfunctionNov 25, 2025Fracture; Fracture

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23644397 ↗
• MalfunctionOct 30, 2025Fracture; Fracture

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23426935 ↗
• MalfunctionOct 22, 2025Fracture; Fracture

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23359854 ↗
• MalfunctionOct 22, 2025Fracture; Fracture

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23358469 ↗
• MalfunctionOct 7, 2025Fracture; Fracture

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23233907 ↗
• MalfunctionJul 28, 2025Fracture; Fracture

  IT WAS REPORTED THAT THE IMPACTOR TIP FRACTURED DURING IMPACTION TO THE GLENOSPHERE WHILE FOLLOWING THE CORRECT SURGICAL TECHNIQUE. SURGERY WAS COMPLETED WITH AN ALTERNATE DEVICE. BROKEN PIECES WERE RETRIEVED FROM THE JOINT SPACE. NO COMPLICATIONS, INJURIES, OR SURGICAL INTERVENTIONS WERE REQUIRED, AND NO FOREIGN BODIES WERE RETAINED DUE TO THIS MALFUNCTION. THE CASE WAS COMPLETED WITHOUT ANY ADVERSE OUTCOMES TO THE PATIENT. ATTEMPTS HAVE BEEN MADE, AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22631777 ↗
• MalfunctionJul 16, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING A PROCEDURE, THE BLACK PLASTIC PIECE ON THE GLENOSPHERE IMPACTOR BROKE WHILE IMPACTING THE COMPONENT. NO PATIENT CONSEQUENCES WERE REPORTED AS A RESULT OF THE EVENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22519349 ↗
• MalfunctionJun 18, 2025Fracture; Material Deformation; Material Twisted/Bent; Fracture; Material Deformation; Material Twisted/Bent

  IT WAS REPORTED THAT THE IMPACTOR FRACTURED. NO COMPLICATIONS, INJURIES, OR SURGICAL INTERVENTIONS WERE REPORTED. ATTEMPTS HAVE BEEN MADE, AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22284874 ↗
• MalfunctionMay 15, 2025Fracture; Fracture

  THERE IS NO UPDATE TO THE PRIOR EVENT DESCRIPTION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22026597 ↗
• MalfunctionMay 13, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING A SHOULDER REVISION, GLENOSPHERE IMPACTORS TIP AND WERE FRACTURED DURING IMPACTION (GLENOSPHERE ASSEMBLY AND INSERTION) WHILE FOLLOWING THE CORRECT SURGICAL TECHNIQUE. PIECES FELL ON THE PATIENT, AND THEY HAD TO BE RETRIEVED, NO FOREIGN BODY WAS RETAINED. ADDITIONALLY, THE BASEPLATE REAMER TIP WAS BENT AND WILL NOT SIT PROPERLY OVER GUIDE PIN. THERE WAS A 45-MINUTE DELAY TO THE PROCEDURE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO COMPLICATIONS, INJURIES, OR SURGICAL INTERVENTIONS WERE REQUIRED, AND NO FOREIGN BODIES WERE RETAINED DUE TO THIS MALFUNCTION. THE CASE WAS COMPLETED WITHOUT ANY ADVERSE OUTCOMES TO THE PATIENT. ATTEMPTS HAVE BEEN MADE, AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22012818 ↗
• MalfunctionMay 5, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING A PROCEDURE, THE 2-PRONG GLENOSPHERE INSERTER/IMPACTOR PLASTIC HEAD BROKE WHILE IMPLANTING THE GLENOSPHERE. NO PATIENT CONSEQUENCES WERE REPORTED AS A RESULT OF THE EVENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21960016 ↗
• MalfunctionApr 28, 2025Fracture; Fracture

  IT WAS REPORTED THAT THE PIN AT THE TIP OF THE DEVICE WAS FOUND TO BE FRACTURED/MISSING PRIOR TO USE DURING A PROCEDURE. NO PATIENT IMPACT WAS REPORTED. 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 21917627 ↗
• MalfunctionApr 23, 2025Fracture; Fracture

  IT WAS REPORTED THAT AFTER AN INITIAL PROCEDURE, THE IMPACTOR TIP WAS FOUND TO BE FRACTURED. THE CORRECT SURGICAL TECHNIQUE WAS USED, AND THE IMPACTOR WAS SUCCESSFULLY USED TO COMPLETE THE PROCEDURE. NO COMPLICATIONS, INJURIES, OR SURGICAL INTERVENTIONS WERE REQUIRED, AND NO FOREIGN BODIES WERE RETAINED DUE TO THIS MALFUNCTION. THE CASE WAS COMPLETED WITHOUT ANY ADVERSE OUTCOMES TO THE PATIENT. ATTEMPTS HAVE BEEN MADE, AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21893655 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K080642, 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, 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-2144-2020 · Apr 17, 2020 · Terminated
  Extremities Item Number: 1)113954 Hybrid Glenoid Glenoid Base, 4 MM 2) XL-115366 Comprehensive Reverse Shoulder Humeral Bearing, ArComXL, 44 MM X 41 MM, Standard 3) XL-115364 Comp
• Z-1750-2020 · Mar 13, 2020 · Terminated
  Comprehensive Humeral Tray Taper Extraction Pliers - Replacement Tips, Model Number 110028522 - Product Usage: Intended to be used in surgery to relieve pain and to replace the gle
• Z-1859-2017 · Feb 17, 2017 · Terminated
  various polyethylene implants Extremities, Shoulders and Elbows BioModular Shoulder System; Comprehensive Shoulder System; Comprehensive Reverse Shoulder System Product Usage: Sh
• Z-1103-2017 · Dec 20, 2016 · Terminated
  Comprehensive Reverse Shoulder System Humeral Tray Model 115340
• Z-1548-2013 · May 15, 2013 · Terminated
  Superior Approach Resection Guide Assembly. Indicated for primary, fracture, or revision total shoulder replacement for the relief of pain.
• Z-2544-2011 · Apr 22, 2011 · Terminated
  Comprehensive reverse shoulder humeral tray with locking ring, 44 mm +5 mm, sterile, single use, REF 115345, Biomet Orthopedics, Warsaw, IN. Biomet Comprehensive Reverse Shoulde
• Z-2542-2011 · Apr 22, 2011 · Terminated
  Bio-modular reverse shoulder humeral tray with lock ring, 44 mm standard, sterile, single use, REF 11-113680, Biomet Orthopedics, Warsaw, IN. Biomet Comprehensive Reverse Shoulder
• Z-2546-2011 · Apr 22, 2011 · Terminated
  Custom bi-angular to reverse shoulder humeral tray 44 mm sterile, REF CP561548, Biomet Orthopedics, Warsaw, IN. Biomet Comprehensive Reverse Shoulder products are indicated fo
• Z-2543-2011 · Apr 22, 2011 · Terminated
  Comprehensive reverse shoulder humeral tray with locking ring, 44 mm +10 mm, sterile, single use, REF 115348, Biomet Orthopedics, Warsaw, IN. Biomet Comprehensive Reverse Should
• Z-2545-2011 · Apr 22, 2011 · Terminated
  Comprehensive reverse shoulder humeral tray with locking ring, 44 mm standard, sterile, single use, REF 115340, Biomet Orthopedics, Warsaw, IN. Biomet Comprehensive Reverse Sho
• Z-2548-2011 · Apr 22, 2011 · Terminated
  Custom biomodular humeral tray 44 mm sterile, REF CP561686, Biomet Orthopedics, Warsaw, IN. Biomet Comprehensive Reverse Shoulder products are indicated for use in patients who
• Z-2541-2011 · Apr 22, 2011 · Terminated
  Bio-modular reverse shoulder humeral tray with lock ring, 44 mm 10 degree angle, sterile, single use, REF 11-113685, Biomet Orthopedics, Warsaw, IN. Biomet Comprehensive Reverse S

…and 5 more.