COMPREHENSIVE SHOULDER SYSTEM 113626Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00880304449770), received between Nov 11, 2019 and Jul 29, 2025 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Difficult to Insert” (1 report).

6 other recalls cover devices cleared under the same FDA submission (K060692); 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJul 29, 2025Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT DURING AN INITIAL SHOULDER ARTHROPLASTY, THE PLACEMENT OF THE STEM WAS UNSUCCESSFUL. IT WAS NOTED THAT IT WAS NOT POSSIBLE TO INSERT THE STEM DEEPLY ENOUGH INTO THE HUMERAL SHAFT. SUBSEQUENTLY, REPEATED REAMING ALSO YIELDED NO IMPROVEMENT. DUE TO EXCESSIVE TENSION, AVULSION OF THE CONJOINED ROTATOR CUFF TENDON OCCURRED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Muscle/Tendon Damage

  MAUDE report 22646882 ↗
• MalfunctionNov 11, 2019Packaging Problem; Packaging Problem

  IT WAS REPORTED DURING THE DISTRIBUTION PROCESS PACKAGING DAMAGE WITH STERILITY BARRIER POTENTIALLY COMPROMISED WAS IDENTIFIED. NO PATIENT OR SURGICAL INVOLVEMENT. NO FURTHER INFORMATION AVAILABLE AT THIS TIME.

  Patient problems: No Patient Involvement

  MAUDE report 9304807 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K060692. One submission often covers many models, so check the product and lot details in each record.

• Z-1543-2020 · Feb 17, 2020 · Terminated
  Comprehensive Shoulder System Mini Humeral Stem 9mm,, Model No. 113629 - Product Usage: The intended use of the comprehensive humeral stem mini is to act as the humeral component o
• Z-0591-2019 · Oct 10, 2018 · Terminated
  Comprehensive Mini Stem, Item No. 113631:
• Z-0980-2018 · Dec 8, 2017 · Terminated
  Humeral Stem 55mm(Size 13) Product Usage: Intended for primary and revision total shoulder arthroplasty as well as hemi-arthroplasty
• Z-0979-2018 · Dec 8, 2017 · Terminated
  Humeral Stem 83mm(Size 17) Product Usage: Intended for primary and revision total shoulder arthroplasty as well as hemi-arthroplasty
• Z-0299-2018 · Jun 5, 2017 · Terminated
  COMP PRIMARY STEM 8MM MINI, model # 113628
• Z-1755-2015 · Apr 16, 2015 · Terminated
  Comprehensive Shoulder System, 4 mm, 122 mm long, Primary Shoulder Stem, Ti-6Al-4V, Standard Length Porous Plasma. Shoulder joint replacement components include humeral stems, hum