DJO SURGICAL 010-55-020Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00888912069960), received between Dec 6, 2020 and Dec 6, 2020 — classified as 1 injury.

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

2 other recalls cover devices cleared under the same FDA submission (K931665); 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.

• InjuryDec 6, 2020Break

  REPORTED INCIDENT - THE HEAD BROKE OFF THE SCREW AS THE SURGEON WAS IMPLANTING IT. THE SCREW SHAFT WAS LEFT IN THE PATIENT AS IT WAS SCREWED IN BEFORE THE HEAD SNAPPED OFF. THE HEAD OF THE SCREW WAS RETRIEVED AND DISCARDED. NO STRAY PIECES WERE LEFT IN THE PATIENT. IT SHOULD BE NOTED THAT THE SURGEON REQUESTED THAT THIS INCIDENT BE REPORTED TO DJO.

  Patient problems: Failure of Implant

  MAUDE report 10955722 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K931665. One submission often covers many models, so check the product and lot details in each record.

• Z-0139-2013 · Sep 28, 2012 · Terminated
  6.5mm Cancellous Bone Screw Intended to be used for the fixation of the acetabular shell or fracture repair.
• Z-2146-2012 · Jul 16, 2012 · Terminated
  djo surgical Screw 6.5 mm, Sz 25mm, low profile. Product is intended for the fixation of the acetabular shell or fracture repair