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DJO SURGICAL 010-55-040Recalls & reported problems

Encore Medical, L.P. · SCREW, CANCELLOUS, 40MM · Class 2

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports
1
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00888912070010), received between Feb 12, 2020 and Feb 12, 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 16, 2026.

Most reported problems

Device problems

  • Break1

Patient problems

  • Failure of Implant1

Recent adverse event reports

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

  • InjuryFeb 12, 2020Break

    REPORTED INCIDENT - DURING SURGERY, A 6.5MM ACETABULAR SCREW BROKE IN HALF WHEN IT WAS BEING IMPLANTED INTO THE PATIENT.

    Patient problems: Failure of Implant

    MAUDE report 9700542 ↗

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

Other Screw, Fixation, Bone devices

All Screw, Fixation, Bone devices →

Sources and updates

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