GPS 531-25-00Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10885862308146), received between Mar 17, 2021 and Apr 18, 2022 — classified as 2 malfunctions.

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

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 18, 2022Break; Break

  IT WAS REPORTED FROM THE US THAT DURING AN ANATOMIC SHOULDER SURGERY THE MODULAR DRIVER TIP SHEARED OFF WHILE SURGEON WAS REAMING GLENOID. THERE WERE NO PARTS OR PIECES FELL INTO THE SURGICAL SITE. THERE WAS NO DELAY OR ADVERSE EVENT TO THE PATIENT. THE PATIENT¿S HEALTH WAS STABLE LEAVING THE OR. PATIENT DEMOGRAPHIC INFORMATION WAS NOT PROVIDED. THE AGENT WAS PRESENT AT THE TIME OF SURGERY. MULTIPLE EMAIL REQUESTS WERE SENT TO THE CONTACTS FOR ADDITIONAL INFORMATION. NO FURTHER INFORMATION HAS BEEN PROVIDED BY THE CONTACTS RELATED TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14135849 ↗
• MalfunctionMar 17, 2021Break; Break

  IT WAS REPORTED THAT DURING SURGICAL USE, THE TIP BROKE OFF THE DRIVER HANDLE WHILE REAMING. IT APPEARED TO GET CAUGHT ON RETRACTOR. NO PIECES FELL INTO THE PATIENT. THERE WAS NO SURGICAL DELAY AND THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11507314 ↗

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