DJO SURGICAL 804-06-324Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00190446844150), received between May 16, 2025 and Sep 18, 2026 — classified as 6 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (6 reports).

8 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.

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.

• InjurySep 18, 2026Detachment of Device or Device Component

  Patient problems: Foreign Body In Patient

  MAUDE report 50831069 ↗
• MalfunctionApr 13, 2026Mechanical Problem; No Apparent Adverse Event

  THE BLUE POST AUGMENT BASEPLATE INSERTER BROKE OFF INTO THE PATIENT. THE SURGEON TRIED TO REMOVED THE BLUE POST WITH A BURR BUT WAS UNSUCCESSFUL AND THE BLUE POST WAS PUSHED FURTHER INTO THE GLENOID. THE SURGEON DECIDED TO LEAVE THE BLUE TIP INTO THE GLENOID. HE REIMPLANTED THE BASEPLATE WITH ANOTHER DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24864592 ↗
• InjuryApr 7, 2026Mechanical Problem

  POST ON THE SPACE PLATE INSERT ARE BROKE WHEN IMPACTING ON BASE PLATE TO PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24811567 ↗
• MalfunctionApr 7, 2026Detachment of Device or Device Component

  INSTRUMENT FAILURE - UPON INSERTING THE ARG BASEPLATE, THE LONG PEG ON THE INSERTER BROKE OFF.

  Patient problems: Foreign Body In Patient

  MAUDE report 24808393 ↗
• InjuryMar 26, 2026Adverse Event Without Identified Device or Use Problem

  BLUE PEG BROKE OFF INTO BASEPLATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24706163 ↗
• InjuryMar 26, 2026Adverse Event Without Identified Device or Use Problem

  THE PEG ON BLUE ARG INSERTER BROKE WHILE IMPACTING AND STAYED IN PATIENT. ATTEMPTS WERE MADE TO GET IT OUT, BUT ULTIMATELY IT WAS UNABLE TO BE RETRIEVED WITHOUT CAUSING SUBSEQUENT DAMAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24706156 ↗
• InjuryMar 18, 2026Detachment of Device or Device Component

  THE SURGEON WAS UTILZING THE GLENOID WEDGE BASEPLATE INSERTER (804-06-324) TO IMPLANT THE GLENOID WEDGE BASEPLATE. AFTER IMPLANT WAS IMPLANTED, THE INSERTER WAS REMOVED AND HANDED BACK TO THE SCRUB TECH. THE SCRUB TECH SHOWED ME THE INSERTER AND WE NOTICED THAT THE PEG WAS MISSING FROM THE GUIDE. THE SURGEON WAS NOTIFIED IMMEDIATELY AND HE DETERMINED THAT THE PEG HAD SNAPPED OFF IN THE PATIENT. HE MADE 4 ATTEMPTS TO REMOVE WITH A HEMOSTAT BUT WAS UNSUCCESSFUL. THE SURGEON DECIDED TO LEAVE THE BROKEN PEG IN THE PATIENT AND CONTINUED TO COMPLETE THE SURGERY.

  Patient problems: Foreign Body In Patient

  MAUDE report 24631468 ↗
• MalfunctionMar 12, 2026Detachment of Device or Device Component

  INSTRUMENT FAILURE - UPON INSERTING OF THE WEDGED ARG BASEPLATE THE LONG PEG ON THE INSERTUER BROKE OFF.

  Patient problems: Foreign Body In Patient

  MAUDE report 24576938 ↗
• MalfunctionFeb 12, 2026Detachment of Device or Device Component

  INSTRUMENT FAILURE - THE LONG PEG ON THIS INSERTER BROKE OFF AND WAS LEFT ON THE PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 24329268 ↗
• MalfunctionOct 16, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE LONG POST BROKE OFF OF BLUE IMPACTOR TIP. BROKEN PIECE WAS STUCK IN THE HOLE, HAD TO BE DRILLED OUT AND REMOVED WITH INSTRUMENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23318676 ↗
• InjuryJul 1, 2025Mechanical Problem; Detachment of Device or Device Component; Mechanical Problem; Detachment of Device or Device Component

  INSTRUMENT FAILURE - THE BLUE POST BROKE OFF WHILE IMPLANTING THE AUGMENT GLENOID. THE 3.5 DRILL BIT BROKE OFF DURING SURGERY IN THE PATIENT. THE PIECE OF THE DRILL BIT WAS LEFT IN THE PATIENT.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 22372572 ↗
• MalfunctionMay 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INSTRUMENT FAILURE - DURING SURGERY, THE BLUE POST ON THE ALTIVATE REVERSE GLENOID BASEPLATE INSERTER WEDGE # 804-06-324 BROKE OFF IN THE PATIENT DURING IMPLANTATION OF THE WEDGE BASEPLATE. THIS CAUSED A 10 MINUTE DELAY WHILE WE DETERMINED HOW TO BEAT REMOVE FROM OUR DRILL HOLE IN ORDER TO PROCEED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22040665 ↗

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-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-2548-2025 · Jul 18, 2025 · Open, Classified
  Brand Name: DJO SURGICAL Product Name: ALTIVATE REVERSE WEDGE GLENOID REAMER SLEEVE Model/Catalog Number: 804-06-310 Product Description: Material: S.S/CoCrMo, Non-Sterile
• 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-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.
• 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.