COMPREHENSIVE SHOULDER SYSTEM 113629Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00880304462649), received between Sep 26, 2023 and Mar 14, 2025 — classified as 2 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (1 report).

1 FDA recall record name this device's identifier.

5 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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Feb 17, 2020Terminated

   A 15mm Shoulder Mini Humeral Stem was misidentified as a 9mm Shoulder Mini Humeral Stem.

   Z-1543-2020 · Root cause: Under Investigation by firm · FDA record ↗

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.

• InjuryMar 14, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

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

  Patient problems: Insufficient Information

  MAUDE report 21611302 ↗
• InjurySep 26, 2023Malposition of Device; Malposition of Device

  IT WAS FURTHER REPORTED THAT DURING THE PROCEDURE, IT WAS NOTED THAT A FUNGAL INFECTION WAS PRESENT. HOWEVER, THE SURGEON NOTED THAT THIS WAS NOT A CONTRIBUTING REASON FOR THE REVISION PROCEDURE.

  Patient problems: Discomfort; Fungal Infection; Loss of Range of Motion; Pain

  MAUDE report 17816932 ↗

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-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