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Dall-Miles 3704-0-510Recalls & reported problems

Howmedica Osteonics Corp. · Stainless Steel Cable Sleeve Set · Class 2 · Implant

All models of Dall-Miles (12)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
2
Deaths reported
0
Injuries reported
2
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613327036374), received between Feb 11, 2019 and Oct 4, 2021 — classified as 2 injuries.

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

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

Device problems

  • Fracture1
  • Packaging Problem1

Patient problems

  • Inadequate Osseointegration1
  • No Consequences Or Impact To Patient1

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • InjuryOct 4, 2021Fracture; Fracture

    SURGEON NOTIFIED ON A CASE THAT POSSIBLY NEEDED A REVISION SURGERY. THE SURGERY WAS DONE A FEW YEARS BACK USING STRYKER IMPLANTS. THE REASON ON THE REVISION SURGERY NEEDED POSSIBLY DUE TO ASEPTIC LOOSENING. PER INFORMATION REQUESTED RESPONSE: "THE CABLE SLEEVE 3704-0-510 , LOT 46496804 WAS BROKEN PRIOR TO SURGERY. DOCTORS SUSPECTED THE CABLE FAILURE."

    Patient problems: Inadequate Osseointegration

    MAUDE report 12569398 ↗
  • InjuryFeb 11, 2019Packaging Problem; Packaging Problem

    DR. FROM THE HOSPITAL REPORTED FOLLOWING EVENT : " AT THE OPENING "DAMAGED DOUBLE PACKAGING: STERILITY NOT GUARANTEED, MATERIAL NOT GIVEN TO SURGERY. USE OF ANOTHER PRODUCT WITH THE SAME REFERENCE.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 8325595 ↗

Other CERCLAGE, FIXATION devices

All CERCLAGE, FIXATION devices →

Sources and updates

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