Comprehensive® SRS Revision 405231Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00880304542365), received between Oct 17, 2025 and Mar 25, 2026 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Fracture” (2 reports).

1 other recall cover devices cleared under the same FDA submission (K111746); 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.

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.

• MalfunctionMar 25, 2026Fracture

  IT WAS REPORTED THAT THE PLASTIC IMPACTOR BROKE WHILE IMPACTING THE PROXIMAL BODY, AND THE CASE WAS COMPLETED USING A DIFFERENT IMPACTOR. THE PATIENT HAD NO CONSEQUENCES OR IMPACT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24686985 ↗
• MalfunctionOct 17, 2025Fracture; Fracture

  IT WAS REPORTED THAT WHILE THE SURGEON WAS ASSEMBLING PROXIMAL BODY THE INSTRUMENT FRACTURED. THERE WAS NO REPORT OF FOREIGN BODY RETAINED OR HARM TO THE PATIENT. ATTEMPT HAS BEEN MADE TO OBTAIN ADDITIONAL INFORMATION. NO ADDITIONAL INFORMATION HAS BEEN RECEIVED AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23322210 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K111746. One submission often covers many models, so check the product and lot details in each record.

• Z-1173-2018 · Feb 28, 2018 · Terminated
  Zimmer Biomet Comprehensive Segmental Revision System (SRS). Orthopedic implants for Proximal Humeral Reconstruction, Distal Humeral Reconstruction, and Total Humeral Reconstructio