DJO SURGICAL 425-99-010Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00888912078962), received between Jan 13, 2017 and Jul 18, 2022 — classified as 3 injuries.

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

1 other recall cover devices cleared under the same FDA submission (K120241); 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryJul 18, 2022Fracture; Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY - THE FEMUR WAS FRACTURED WHEN INSERTING THE STEM DURING THIS PRIMARY HIP CASE AND IT TURNED IT INTO A REVISION CASE.

  Patient problems: Insufficient Information

  MAUDE report 15048498 ↗
• InjurySep 18, 2020Fracture; Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY - THE PATIENT HAD A PERIPROSTHETIC FRACTURE.

  Patient problems: Insufficient Information

  MAUDE report 10553704 ↗
• InjuryJan 13, 2017Unstable

  REVISION SURGERY - DUE TO INSTABILITY AND LOSS OF MOTION.

  Patient problems: Loss of Range of Motion

  MAUDE report 6250851 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K120241. One submission often covers many models, so check the product and lot details in each record.

• Z-1692-2020 · Jul 10, 2018 · Open, Classified
  djosurgical Linear Neck Trials with Spring Sides, Standard, nonsterile, REF S-200635; and djosurgical Linear Neck Trials with Spring Sides, Lateral, nonsterile, REF S-200636. The