Comprehensive® SRS 211244Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00880304540620), received between Jul 25, 2025 and Jul 25, 2025 — classified as 1 injury.

1 other recall cover devices cleared under the same FDA submission (K111746, K173411, K223631); 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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryJul 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT ENTERED CLINICAL STUDY UPON REVISION OF RIGHT RTSA WITH REPAIR OF COMMUTED HUMERAL FRACTURE. SUBSEQUENTLY, THE PATIENT EXPERIENCED ONGOING PAIN WITH NO IDENTIFIED IMPLANT ABNORMALITIES AND RECEIVED INJECTION APPROXIMATELY 4 YEARS POST-IMPLANTATION WITH RESOLUTION. REMAINS IMPLANTED AT STUDY COMPLETION.

  Patient problems: Implant Pain; Pain

  MAUDE report 22610546 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K111746, K173411, K223631. 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