DJO SURGICAL 804-06-310Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00190446843818), received between Jan 8, 2025 and Aug 7, 2025 — classified as 5 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Mechanical Problem” (8 reports).

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

7 other recalls cover devices cleared under the same FDA submission (K233481); 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 18, 2026.

Recalls naming this device

1. Jul 18, 2025Class IIOpen, Classified

   Their is a potential that the reamer may kick or bind up during or immediately prior to use.

   Z-2548-2025 · Root cause: Device Design · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INSTRUMENT FAILURE - REAMER BINDED WHILE WE WERE REAMING AND SURGEON BELIEVES IT CAUSED A CRACK IN THE GLENOID.

  Patient problems: Bone Fracture(s)

  MAUDE report 22745625 ↗
• InjuryJun 18, 2025Mechanical Problem; Mechanical Problem

  COMPLAINT - THE REAMER WOULD BIND UP AND FREEZE DURING THE PROCEDURE. WE DISASSEMBLED AND CLEAN IT MULTIPLE TIMES AND IT CONTINUED TO BIND UP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22288618 ↗
• MalfunctionJun 13, 2025Mechanical Problem; Mechanical Problem

  COMPLAINT - THE REAMERS WERE BINDING UP DUE TO BONE DEBRIS. THIS CAUSED A 15-20 MINUTE DELAY IN SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22207815 ↗
• MalfunctionJun 4, 2025Mechanical Problem; Mechanical Problem

  COMPLAINT - IT WAS REPORTED THAT DURING OUR CASE WITH DR, WE WERE COMPLETING A REVERSE AUGMENTED GLENOID WHEN THE MAIN OFF AXIS REAMER AND ITS COMPONENTS SEEMINGLY BOUND UP ON EACH OTHER WHEN ATTEMPTING TO REAM FOR THE WEDGE BASEPLATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22146567 ↗
• MalfunctionMay 21, 2025Mechanical Problem; Adverse Event Without Identified Device or Use Problem; Mechanical Problem; Adverse Event Without Identified Device or Use Problem

  INSTRUMENT FAILURE - THE REAMER SEIZED UP WHILE REAMING, DESPITE ALL THE PRECAUTIONS BEING TAKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22066795 ↗
• MalfunctionMay 12, 2025Mechanical Problem; Mechanical Problem

  INSTRUMENT FAILURE - THE REAMER SEIZED UP WHILE REAMING, DESPITE ALL THE PRECAUTIONS BEING TAKEN FRACTURING THE GLENOID DOWN THE MIDDLE.

  Patient problems: Bone Fracture(s)

  MAUDE report 22007089 ↗
• InjuryMay 7, 2025Mechanical Problem; Mechanical Problem

  INSTRUMENT FAILURE - THE INTERNAL SHAFT ON THE WEDGE REAMER WAS BENT, WE PULLED RESET THE SECOND BOSS AND WEDGE REAMER AND STILL BINDING REAMER SHAFT, CAUSING A 30 MINUTE DELAY IN SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21980614 ↗
• InjuryMar 26, 2025Mechanical Problem; Mechanical Problem

  INSTRUMENT FAILURE - WHEN THE DOCTOR WENT TO USE THE REAMER, THE REAMER WOULD GET BOUND UP BEFORE HE EVEN WAS ABLE TO PLACE IT IN THE PATIENT. WE OPENED UP ANOTHER SET TRIED WITH THE OTHER ONE AND IT DID THE SAME THING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21704302 ↗
• InjuryMar 26, 2025Mechanical Problem; Mechanical Problem

  INSTRUMENT FAILURE - WHEN THE DOCTOR WENT TO USE THE REAMER, THE REAMER WOULD GET BOUND UP BEFORE HE EVEN WAS ABLE TO PLACE IT IN THE PATIENT. WE OPENED UP ANOTHER SET TRIED WITH THE OTHER ONE AND IT DID THE SAME THING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21704301 ↗
• MalfunctionMar 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INSTRUMENT FAILURE -REAMER WOULD NOT SPIN FREELY WITH FACING REAMER AND BOSS REAMER ENGAGE INTO IT. (IT BOUND), CAUSING A 25 MINUTE DELAY IN SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21670664 ↗
• InjuryMar 6, 2025No Apparent Adverse Event; No Apparent Adverse Event

  PRIMARY SURGERY - THE OFFSET WEDGE REAMER ASSEMBLY LOCKED UP, THE INSTRUMENTS WERE DISASSEMBLED, CLEANED AND REASSEMBLED MULTIPLE TIME WITH THE SAME OUTCOME CAUSING A 20 MINUTE DELAY IN SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21542796 ↗
• MalfunctionJan 8, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INSTRUMENT FAILURE - THE REAMER SEIZED UP WHILE REAMING THE GLENOID DESPITE ALL THE PRECAUTIONARY STEPS BEING BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21108222 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K233481. One submission often covers many models, so check the product and lot details in each record.

• Z-2549-2025 · Jul 18, 2025 · Open, Classified
  Brand Name: DJO SURGICAL Product Name: FA S Altivate Reverse Glenoid Tray Model/Catalog Number: None Software Version: NA Product Description: Enovis" shoulder devices are intended
• Z-2546-2025 · Jul 18, 2025 · Open, Classified
  Brand Name: DJO SURGICAL Product Name: ALTIVATE REVERSE WEDGE GLENOID REAMER HEAD Model/Catalog Number: 804-06-311 Product Description: Material: S.S/Nitronic, Non-Sterile
• Z-2547-2025 · Jul 18, 2025 · Open, Classified
  Brand Name: DJO SURGICAL Product Name: ALTIVATE REVERSE WEDGE GLENOID REAMER BOSS DRILL, 6.5mm Model/Catalog Number: 804-06-312 Product Description: Material: S.S., Non Sterile
• Z-2009-2025 · May 28, 2025 · Open, Classified
  Brand Name: ALTIVATE REVERSE Product Name: ALTIVATE REVERSE TORX PERIPHERAL SCREW, 22mm Model/Catalog Number: 506-04-122 Software Version: NA Product Description: Encore Medical L.
• Z-2010-2025 · May 28, 2025 · Open, Classified
  Brand Name: ALTIVATE REVERSE Product Name: ALTIVATE REVERSE TORX PERIPHERAL SCREW, 18mm Model/Catalog Number: 506-04-118 Software Version: NA Product Description: Encore Medical L.
• Z-2008-2025 · May 28, 2025 · Open, Classified
  Brand Name: ALTIVATE REVERSE Product Name: ALTIVATE REVERSE TORX PERIPHERAL SCREW, 26mm Model/Catalog Number: 506-04-126 Software Version: NA Product Description: Encore Medical L.
• Z-2011-2025 · May 28, 2025 · Open, Classified
  Brand Name: ALTIVATE REVERSE Product Name: ALTIVATE REVERSE TORX PERIPHERAL SCREW, 30mm Model/Catalog Number: 506-04-130 Software Version: NA Product Description: Encore Medical L.