DJO SURGICAL 520-54-318Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00190446176268), received between May 22, 2020 and Dec 26, 2024 — classified as 4 injuries.

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 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.

• InjuryDec 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY - DUE TO PATIENT WAS TOO TIGHT.

  Patient problems: Loss of Range of Motion

  MAUDE report 21023567 ↗
• InjuryAug 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY - DUE TO INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 19914511 ↗
• InjuryFeb 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY - REQUIRED INTERVENTION TO PREVENT PERMANENT IMPAIRMENT/DAMAGE.

  Patient problems: Insufficient Information

  MAUDE report 16406016 ↗
• InjuryMay 22, 2020Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY - PATIENT HAD PAIN. HE MAY HAVE FELL AND TORN ROTATOR CUP.

  Patient problems: Pain

  MAUDE report 10083272 ↗

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 # 520-16
• 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
• 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-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-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