G7® 110003451Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00887868462498), received between Sep 13, 2022 and Jun 10, 2025 — classified as 7 malfunctions.

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

3 other recalls cover devices cleared under the same FDA submission (K121874); 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 10, 2025Difficult to Insert; Material Twisted/Bent; Difficult to Insert; Material Twisted/Bent

  IT WAS REPORTED THAT DUE TO REPETITIVE HAMMER IMPACTION ON THE PROXIMAL PART OF THE G7 STRAIGHT INSERTER DEVICE, THE METAL PART WITH THE THREAD THAT GOES INSIDE TO CAPTURE THE SHELL WAS DIFFICULT TO INSERT DUE TO THE METAL BENDING OVER THE HOLE TO SLIDE THE PART IN. NO KNOWN IMPACT OR CONSEQUENCE TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22177931 ↗
• MalfunctionMar 28, 2025Difficult to Insert; Material Twisted/Bent; Damaged Thread; Difficult to Insert; Material Twisted/Bent; Damaged Thread

  IT WAS REPORTED THAT THE HANDLE AND THREAD ARE DAMAGED. THERE WAS NO KNOWN IMPACT OR CONSEQUENCES TO THE PATIENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21717864 ↗
• MalfunctionMar 5, 2025Damaged Thread; Damaged Thread

  NO FURTHER INFORMATION AT THE TIME OF THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21526212 ↗
• MalfunctionOct 15, 2024Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE MODULAR INSERTER AND SHAFT ARE DAMAGED. UNABLE TO THREAD AND UNTHREAD SHAFT IN AND OUT OF INSERTER. THE PIECE WAS ASSEMBLED AND WAS NOT ABLE TO BE DISASSEMBLED WITHOUT MUCH FORCE OR POSSIBLE FARTHER DAMAGE. THERE WAS NO IMPACT ON SURGERY. SURGERY WAS COMPLETED WITH ORIGINAL DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20453013 ↗
• MalfunctionAug 27, 2024Mechanical Problem; Separation Failure; Mechanical Problem; Separation Failure

  THERE IS NO UPDATE TO THE PRIOR EVENT DESCRIPTION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20079518 ↗
• MalfunctionApr 19, 2023Fracture; Fracture

  IT WAS REPORTED THAT THE THREADS ON THE STRAIGHT INSERTER HANDLE FROM G7 EFFICIENT TRAY BROKE OFF. NO PATIENT OR PROCEDURAL IMPACT. THERE IS NO ADDITIONAL INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16771114 ↗
• MalfunctionSep 13, 2022Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  IT WAS REPORTED AFTER IMPLANTATION AND WHEN LOOSENING THE SOCKET, THE BALL HEX DRIVER BROKE OFF. THE SHELL COULD NO LONGER BE DETACHED AFTER REPEATED ATTEMPTS FROM THE INSERT HANDLE AND HAD TO BE REMOVED TOGETHER WITH THE PAN. AN ALTERNATE DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO ADVERSE CONSEQUENCES WERE REPORTED. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15408980 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K121874. One submission often covers many models, so check the product and lot details in each record.

• Z-0007-2023 · Aug 25, 2022 · Open, Classified
  G7 Acetabular System, Acetabular Shell, Item numbers Item Numbers: 010000663 (52 MM E), 010000667 (60 MM G). used in hip arthroplasty
• Z-1838-2014 · May 7, 2014 · Terminated
  G7 Acetabular System Positioning Guide Post, orthopedic surgical instrument for hip prosthesis. PN:110003500.
• Z-1837-2014 · May 7, 2014 · Terminated
  G7 Acetabular System Positioning Guide Rod, orthopedic surgical instrument for hip prosthesis PN 110003458.