Comprehensive Modular Hybrid Glenoid SSI002231Recalls & reported problems

Summary

No MAUDE adverse event reports in our data reference this device identifier directly.

1 FDA recall record name this device's identifier.

4 other recalls cover devices cleared under the same FDA submission (K060694); 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.

Recalls naming this device

1. Aug 21, 2019Class IITerminated

   Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning issue.

   Z-0526-2020 · Root cause: Environmental control · Recall details · FDA record ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K060694. One submission often covers many models, so check the product and lot details in each record.

• Z-2216-2017 · Apr 26, 2017 · Terminated
  Modular Hybrid Glenoid Base Large for the Comprehensive Shoulder System, The product is placed into an AlOx coated PET pouch and vacuum sealed with an Argon flush. The vacuum seale
• 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-1658-2008 · Mar 13, 2008 · Terminated
  Biomet Hybrid Glenoid Boss Cutter; item 406150. - Surgical instrument used to prepare the natural shoulder glenoid surface for implanting a Hybrid Glenoid component. This instrume
• Z-0660-2013 · Dec 6, 0012 · Terminated
  PT113950 PT HYBRID Glenoid Post Regenerex porous titanium construct Sterile R Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented