DJO SURGICAL 425-99-008Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00888912078948), received between Aug 20, 2020 and Sep 15, 2021 — classified as 2 injuries.

The most frequently reported specific device problem is “Measurement System Incompatibility” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjurySep 15, 2021Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY - DUE TO FRACTURE.

  Patient problems: Bone Fracture(s)

  MAUDE report 12475377 ↗
• InjuryAug 20, 2020Measurement System Incompatibility

  COMPLAINT - SURGEON SAYS THIS IMPLANT IS OFF BY AT LEAST 1 CM COMPARED TO THE BROACH. TWO ADDITIONAL BROACH TRAYS WERE OPENED TO MAKE SURE IT WASN'T THE CURRENT BROACH. THERE IS NOT VISUAL DIFFERENCE. THE NEXT CASE ALSO USED AN 8 LATERAL STEM AND EVERYTHING IS FINE. THE SURGEON WANTED THIS DOCUMENTED AND FOR SOMEONE ON THE HIP TEAM TO BE NOTIFIED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10431333 ↗

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