GPS 531-07-05Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10885862542038), received between Feb 24, 2021 and Feb 7, 2022 — classified as 2 malfunctions.

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

1 FDA recall record name this device's identifier, 1 still open.

1 other recall 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.

Recalls naming this device

1. Jun 5, 2023Open, Classified

   The ball and spring housed within the locking mechanism of the handle can dislodge during disassembly or during impaction.

   Z-2050-2023 · Root cause: Process control · Recall details · FDA record ↗

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.

• MalfunctionFeb 7, 2022Break; Break

  IT WAS REPORTED THAT THE BALL BEARING AND SPRING FROM THE GPS GLENOID IMPACTOR HANDLE DISLODGED INSIDE OF PATIENT WHEN THE SURGEON IMPACTED THE GLENOID BASEPLATE. THE SURGEON BECAME AWARE WHEN THE SPRING WAS LOCATED DURING THE CASE. POST OP AP X RAY TAKEN SHOWS NO BALL BEARING LEFT IN THE PATIENT. THERE WAS LESS THAN A 5 MINUTE SURGICAL DELAY. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

  Patient problems: Unintended Radiation Exposure

  MAUDE report 13476909 ↗
• MalfunctionFeb 24, 2021Break; Break

  AS REPORTED, THE STERILE PROCESSING STAFF MEMBER RECEIVED THE BASEPLATE STILL ATTACHED TO THE HANDLE. WHEN ATTEMPTING TO SEPARATE THE 2 PIECES, THE BALL BEARING SECURING THE SPRING AND LOCKING MECHANISM OF THE BASEPLATE HAS DROPPED OUT. THIS WAS DONE TO WASH THE INSTRUMENTS. THERE WAS NO PATIENT INVOLVEMENT AND THE DEVICES ARE RETURNING.

  Patient problems: No Patient Involvement

  MAUDE report 11371607 ↗

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-0603-2018 · Jul 11, 2017 · Terminated
  Exactech GPS Total Shoulder Application 3.2mm Vix Bit Orthopedic surgical tool