DJO SURGICAL 010-55-025Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00888912069977), received between Jul 27, 2016 and Nov 14, 2017 — classified as 4 injuries.

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

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryNov 14, 2017Inadequacy of Device Shape and/or Size

  REVISION SURGERY - DUE TO THE PATIENT COMPLAINING OF DISCOMFORT. THE SCREW WAS A LITTLE TOO LONG.

  Patient problems: Discomfort; No Code Available

  MAUDE report 7029653 ↗
• InjurySep 27, 2017Break; Detachment Of Device Component

  COMPLAINT/PRIMARY SURGERY - THE SCREW HEAD BROKE OFF THE SHAFT AS THE SURGEON WAS SCREWING IT IN THE ACETABULAR CUP.

  Patient problems: No Information

  MAUDE report 6899486 ↗
• InjuryDec 22, 2016Device Slipped

  PRIMARY SURGERY - THE ACETABULAR SCREW POST-OPERATIVELY WAS SCREWED THROUGH THE SCREW HOLE. THIS WAS DETERMINED ON THE POST-OP X-RAY.

  Patient problems: No Information

  MAUDE report 6201434 ↗
• InjuryJul 27, 2016Break; Detachment Of Device Component

  PRIMARY SURGERY - DUE TO THE SCREW HEAD BREAKING OFF WHILE IMPLANTING THE SCREW. IT WAS DISCOVERED ON (B)(6) 2016 THAT PART OF THE SCREW REMAINED IN THE PATIENT.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 5826596 ↗

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