DJO SURGICAL 520-01-016Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00888912024921), received between Apr 14, 2016 and Mar 30, 2026 — classified as 5 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (1 report).

4 other recalls cover devices cleared under the same FDA submission (K080402); 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryMar 30, 2026Adverse Event Without Identified Device or Use Problem

  PATIENT FELT DISCOMFORT MALE.

  Patient problems: Implant Pain

  MAUDE report 24720553 ↗
• InjuryJun 6, 2022Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY DUE TO PAIN.

  Patient problems: Pain

  MAUDE report 14605629 ↗
• InjuryMar 20, 2018Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY - DUE TO SUBSCAPULARIS FAILURE. THE SURGEON CONVERTED TO A REVERSE SHOULDER.

  Patient problems: Excessive Tear Production

  MAUDE report 7355326 ↗
• InjuryJan 6, 2017Naturally Worn

  REVISION SURGERY - DUE TO THE PATIENT HAVING COMPLAINED OF DISCOMFORT AND OF DISLOCATION AFTER A FALL. AFTER THE REVISION WAS COMPLETE THE SURGEON CONCLUDED THE IMPLANTS WERE ALL IN PROPER POSITION AND IN GOOD CONDITION, BUT THE PATIENT HAD NO ROTATOR CUFF REMAINING AND NEEDED A REVERSE SHOULDER IMPLANT.

  Patient problems: Discomfort; Fall; Joint Dislocation

  MAUDE report 6230487 ↗
• InjuryApr 14, 2016Device Dislodged or Dislocated

  REVISION SURGERY - DUE TO THE PATIENT SUFFERING A DISLOCATION.

  Patient problems: Joint Dislocation

  MAUDE report 5577770 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K080402. One submission often covers many models, so check the product and lot details in each record.

• Z-0801-2011 · Nov 5, 2010 · Terminated
  Turon Shoulder System Instrumentation, Turon Pegged Glenoid Drill Guide, REF 804-25-024, DJO Surgical
• Z-0798-2011 · Nov 5, 2010 · Terminated
  Turon Shoulder System Instrumentation, Turon Humeral Head Trials, DJO Surgical
• Z-0800-2011 · Nov 5, 2010 · Terminated
  Turon Shoulder System Instrumentation, Turon Trial Pegged Glenoid, DJO Surgical
• Z-0799-2011 · Nov 5, 2010 · Terminated
  Turon Shoulder System Instrumentation, Turon Trial Humeral Neck, DJO Surgical