Dall-Miles 3704-0-050Recalls & 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
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07613327036350), received between Apr 8, 2019 and Mar 1, 2021 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Fracture” (2 reports).
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
- Fracture2
- Break1
- Crack1
- Material Split, Cut or Torn1
Patient problems
- No Consequences Or Impact To Patient3
- Insufficient Information1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 1, 2021Fracture; Fracture
WHEN TIGHTENING D/M CABLE WITH SINGLE TENSIONER, CABLE WAS BROKEN INSIDE THE TENSIONER. SURGEON TIGHTENED AS USUAL.
Patient problems: Insufficient Information
MAUDE report 11396282 ↗MalfunctionSep 12, 2019Fracture; Material Split, Cut or Torn; Fracture; Material Split, Cut or Torn
THE PRODUCT IS TORN APART. REPLACEMENT WAS AVAILABLE. SURGICAL DELAY OF 30 MIN. NOT LONGER.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9006316 ↗MalfunctionApr 16, 2019Crack; Crack
DURING THE PROCEDURE, PLACING THE DALL MILES CABLES ON THE FEMUR, WHILE STRETCHING THE CABLE WITH THE INSTRUMENT REF: (B)(4) SINGLE SIDED TENSIONER, THE CABLE CRACK. THE NEW DALL MILES CABLES WITH THE SAME REF NUMBER WAS USED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8518280 ↗MalfunctionApr 8, 2019Break; Break
BREAKING THE DALL MILES CABELE DURING IMPLANTING (REF: 3704-0-050, LOT: 69107907); SURGERY ID: (B)(6); ANOTHER CABEL NEEDED. UPDATE: "PATIENT HAS REPORTED THE SYMPTOMS OF PAIN WITHIN THE PROXIMAL FEMUR; THE IMAGING SHOWED A RUPTURE OF THE BONE AND DISTAL MIGRATION OF THE STEM; REVISION TREATMENT WITH THE AESCULAP REVISION FUNCTION AND STRYKER DALL MILES SYSTEM - ONE OF THE CABLES SPRANG UP DURING TENSIONING. REPLACED WITH ANOTHER CABLE. NO ADDITIONAL COMMENTS. CONDITION OF THE PATIENT AFTER THE SURGERY VERY GOOD - BROKEN CABLE SUCCESSFULLY REPLACED." LEFT SIDE; SURGICAL DELAY: 10 MIN.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8493259 ↗
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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