DJO SURGICAL 520-50-318Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00190446176237), received between Jan 3, 2018 and May 16, 2025 — classified as 6 injuries.

The most frequently reported specific device problem is “Positioning Problem” (1 report).

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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryMay 16, 2025Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY - DUE TO INSTABILITY.

  Patient problems: Joint Laxity

  MAUDE report 22040678 ↗
• InjuryAug 9, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY - DUE TO PAIN.

  Patient problems: Implant Pain

  MAUDE report 17495070 ↗
• InjuryMar 31, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY - DUE TO PAIN AND LOSS OF MOTION.

  Patient problems: Implant Pain; Loss of Range of Motion

  MAUDE report 16660276 ↗
• InjuryAug 25, 2021Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY - DUE TO DISLOCATION AND REVISED TO A REVERE.

  Patient problems: Joint Dislocation

  MAUDE report 12367343 ↗
• InjuryJun 23, 2021Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY - PATIENT HAD INFECTION. REMOVED AND REPLACED THE HEAD AND NECK.

  Patient problems: Unspecified Infection

  MAUDE report 12055234 ↗
• InjuryJan 3, 2018Positioning Problem

  REVISION SURGERY - DUE TO THE PATIENT HAVING LIMITED RANGE OF MOTION WHEN SHE CAME TO HER 6 WEEK FOLLOW UP. THE PATIENT HAD NO PAIN. THE SURGEON TOOK AN XRAY OF THE SHOULDER AND BELIEVED THE HUMERAL HEAD WAS SITTING TOO HIGH ON THE GLENOID. THIS APPEARED TO LOOK DIFFERENT FROM THE PATIENT'S 2 WEEK FOLLOW UP XRAY.

  Patient problems: Loss of Range of Motion

  MAUDE report 7161368 ↗

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-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-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-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