DJO SURGICAL 425-98-016Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00888912078894), received between Apr 19, 2022 and Apr 19, 2022 — classified as 1 injury.

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

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryApr 19, 2022Device Dislodged or Dislocated

  REVISION SURGERY - DUE TO BIPOLAR WAS DISLOCATED. LINEAR STEM WAS LOOSE AND INTERNALLY ROTATED. EMPOWR DUAL MOB WAS USED. NEW STEM WAS IMPLANTED.

  Patient problems: Joint Dislocation

  MAUDE report 14142720 ↗

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