DJO SURGICAL 804-07-421Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00190446284369), received between Jan 19, 2022 and Feb 16, 2022 — classified as 1 injury, 1 malfunction.

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

6 other recalls cover devices cleared under the same FDA submission (K162024); 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.

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 16, 2022Break

  COMPLAINT: INSTRUMENT BROKE DURING SURGERY.

  Patient problems: Insufficient Information

  MAUDE report 13542103 ↗
• InjuryJan 19, 2022Break

  INSTRUMENT FAILURE ITEMS WERE BROKEN DURING A SHOULDER SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13290330 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K162024. One submission often covers many models, so check the product and lot details in each record.

• Z-2331-2021 · Jun 28, 2021 · Open, Classified
  AltiVate Anatomic Shoulder System for the following Part Numbers: 1. Part # 520-08-00, Rev. C., 2. Part # 520-10-000, 3. Part # 520-12-000, 4. Part # 520-14-000, 5. Part # 520-
• Z-1258-2018 · Jan 29, 2018 · Completed
  Altivate Anatomic(TM) INSTRUMENTATION, PEGGED GLENOID TRIAL, SIZE 46mm, REF 804-07-460 Product Usage: The AltiVate Anatomic Shoulder System is a total shoulder system indicated as
• Z-1256-2018 · Jan 29, 2018 · Completed
  Altivate Anatomic(TM) INSTRUMENTATION, PEGGED GLENOID TRIAL, SIZE 38mm, REF 804-07-380 Product Usage: The AltiVate Anatomic Shoulder System is a total shoulder system indicated as
• Z-1257-2018 · Jan 29, 2018 · Completed
  Altivate Anatomic(TM) INSTRUMENTATION, PEGGED GLENOID TRIAL, SIZE 42mm, REF 804-07-420 Product Usage: The AltiVate Anatomic Shoulder System is a total shoulder system indicated as
• Z-1259-2018 · Jan 29, 2018 · Completed
  Altivate Anatomic(TM) INSTRUMENTATION, PEGGED GLENOID TRIAL, SIZE 50mm, REF 804-07-500 Product Usage: The AltiVate Anatomic Shoulder System is a total shoulder system indicated as
• Z-1260-2018 · Jan 29, 2018 · Completed
  Altivate Anatomic(TM) INSTRUMENTATION, PEGGED GLENOID TRIAL, SIZE 54mm, REF 804-07-540 Product Usage: The AltiVate Anatomic Shoulder System is a total shoulder system indicated