GPS 531-01-04Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10885862527776), received between Nov 13, 2020 and Nov 13, 2020 — 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.

• InjuryNov 13, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE BASE OF THE PATIENT¿S CORACOID BONE WAS FRACTURED. MOST LIKELY FROM THE SCREWS USED TO ATTACHED THE ¿G¿ TRACKER ONTO THE CORACOID. THIS WAS DISCOVERED PRIOR TO DRILLING THE COMPRESSION SCREWS INTO THE REVERSE BASEPLATE. THERE WAS NO SURGICAL DELAY. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

  Patient problems: Bone Fracture(s)

  MAUDE report 10837228 ↗

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