GPS 531-20-00Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10885862319272), received between Jul 25, 2025 and Jul 25, 2025 — classified as 1 injury.

2 other recalls cover devices cleared under the same FDA submission (K162567, K173372); 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 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 THE PATIENT UNDERWENT AN INITIAL REVERSE TOTAL SHOULDER REPLACEMENT ON THE LEFT SIDE. SUBSEQUENTLY, THE PATIENT EXPERIENCED A SCAPULAR FRACTURE DURING IMPLANTATION OF DEVICES. DRILLING CENTER CAGE FOR ANATOMIC BASE PLATE, DRILL CAUGHT SCAPULAR VAULT AND FRACTURED GLENOID AT PIN SITE. AS A RESULT, THE PATIENT WAS CONVERTED TO RTSA INTRA-OP WITHOUT ISSUE. NO FURTHER IMPACT TO THE PATIENT WAS REPORTED. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: Bone Fracture(s); Periprosthetic fracture

  MAUDE report 22613389 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K162567, K173372. One submission often covers many models, so check the product and lot details in each record.

• Z-2050-2023 · Jun 5, 2023 · Open, Classified
  Exactech Shoulder GPS Impactor Handle, Catalog #531-07-05.
• Z-0603-2018 · Jul 11, 2017 · Terminated
  Exactech GPS Total Shoulder Application 3.2mm Vix Bit Orthopedic surgical tool