Dall-Miles 6704-0-420Recalls & reported problems
Howmedica Osteonics Corp. · Beaded Cable and 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
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613327036435), received between Apr 26, 2019 and Oct 3, 2025 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Break” (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.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Break1
Patient problems
- Fistula1
- No Consequences Or Impact To Patient1
- Unspecified Infection1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryOct 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
MalfunctionApr 26, 2019Break; Break
DURING SURGERY, THE WIRE WAS BROKEN WHEN THE SURGEON APPLIED TENSION TO THE WIRE. UPDATE: 2-3 MINUTES SURGICAL DELAY. LEFT SIDE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8557772 ↗
Other CERCLAGE, FIXATION devices
- ZipFix 03.501.080Synthes GmbH · CERCLAGE, FIXATION236 reports
- CONTROL 1739-28-000Depuy Orthopaedics, Inc. · CERCLAGE, FIXATION52 reports
- Dall-Miles 6704-0-110Howmedica Osteonics Corp. · CERCLAGE, FIXATION1 recall1 report
- Tritium® Sternal Cable Plate System 86-27-12-S12Pioneer Surgical Technology, Inc. · CERCLAGE, FIXATION1 recall0 reports
- Accord 71340007Smith & Nephew, Inc. · CERCLAGE, FIXATION47 reports
- ZipFix 08.501.001.01SSynthes GmbH · CERCLAGE, FIXATION39 reports
- NA 298.801.01SSynthes GmbH · CERCLAGE, FIXATION33 reports
- ZipFix 08.501.001.05SSynthes GmbH · CERCLAGE, FIXATION29 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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