DJO SURGICAL 508-65-000Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00190446822837), received between Nov 20, 2025 and May 26, 2026 — classified as 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Mechanical Problem” (2 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryMay 26, 2026Device Dislodged or Dislocated

  REVISION SURGERY - DUE TO THE BASEPLATE AND THE TAPER DISENGAGED.

  Patient problems: Joint Laxity

  MAUDE report 25294153 ↗
• InjuryMay 8, 2026Adverse Event Without Identified Device or Use Problem

  INFECTION PRESENTED 3 WEEKS POST OP, PT REQUIRED FULL REMOVAL, DISINFECTION, AND IMPLANT REVISION WITH SAME SIZED IMPLANTS.

  Patient problems: Unspecified Infection

  MAUDE report 25130572 ↗
• MalfunctionMar 4, 2026Mechanical Problem

  COMPLAINT - DOCTOR DR (B)(6) WENT TO TRIAL THE GLENOSPHERE IN THE PATIENT, AND THE TAPER IN THE ARG BASEPLATE DID NOT SEAT. DOCTOR ENSURED THAT ALL OF THE BONE AND TISSUE WAS CLEARED AWAY TO GET THE GLENOSPHERE TRIAL DOWN. HE TRIED MULTIPLE TIMES AND WAS UNSUCCESSFUL. DOCTOR ALSO PUT THE TRIAL 36 +4 GLENOSPHERE TRIAL IN AND THE INSERTER HANDLE COLD FUSED WHEN HE WAS TRYING TO GET THE GLENOSPHERE TO ENGAGE. AFTER MULTIPLE ATTEMPTS WITH THE TAPER THAT COMES IN THE ARG BASEPLATE, DOCTOR HAD THE EXTRA TAPER OPENED, AND WE CONTINUED TO HAVE THIS PROBLEM. AT THIS POINT, WE CALLED AN ENGINEER AND SHE SUGGEST WE TAKE THE BASEPLATE OUT AND PUT A NEW ONE IN. WHEN THE SCREWS WERE REMOVED FROM THIS BASEPLATE, THE THREADS GOT DAMAGED, AND HE ENDED UP REPLACING ALL OF THE PERIPHERAL SCREWS. THERE WAS A 45-60-MINUTE DELAY IN SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24510091 ↗
• InjuryNov 20, 2025Mechanical Problem; Material Split, Cut or Torn; Mechanical Problem; Material Split, Cut or Torn

  COMPLAINT - DELAY 50 MINUTE DELAY IN SURGERY AND BROKEN/ FRAGMENTED PIECES LEFT IN PATIENT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23601603 ↗

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-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-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-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-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-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-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.