Dall-Miles 6704-8-240Recalls & reported problems
Howmedica Osteonics Corp. · Cable · Class 2 · Implant
All models of Dall-Miles (12)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07613327036497), received between Feb 15, 2022 and Jan 29, 2025 — classified as 3 injuries.
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.
Reports received per month
Most reported problems
Device problems
- Fracture2
- Loosening of Implant Not Related to Bone-Ingrowth1
Patient problems
- Insufficient Information2
- Pain1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryJan 29, 2025Fracture; Fracture
REVISION PROCEDURE OF PROXIMAL FEMUR GMRS. MULTIPLE PREVIOUS REVISIONS; CABLES IMPLANTED DURING PROCEDURE (B)(6) 2023. NO DETAILS AVAILABLE OF PROCEDURES PRIOR TO THIS DATE. DALL MILES CABLE HAD SNAPPED AND FRAYED IN THE PATIENT. CABLES AND CABLE GRIP REMOVED AND FRAYED METAL REMOVED UNDER X RAY GUIDANCE. NO NEW IMPLANTS WERE PUT IN. ALL OF THE ITEMS ARE STILL IN PATIENT EXCEPT FOR THE CABLES AND CABLE GRIP WHICH WERE REMOVED DURING THIS EVENT.
Patient problems: Insufficient Information
MAUDE report 21263920 ↗InjuryJan 29, 2025Fracture; Fracture
REVISION PROCEDURE OF PROXIMAL FEMUR GMRS. MULTIPLE PREVIOUS REVISIONS: CABLES IMPLANTED DURING PROCEDURE (B)(6) 2023. NO DETAILS AVAILABLE OF PROCEDURES PRIOR TO THIS DATE. DALL MILES CABLE HAD SNAPPED AND FRAYED IN THE PATIENT. CABLES AND CABLE GRIP REMOVED AND FRAYED METAL REMOVED UNDER X RAY GUIDANCE. NO NEW IMPLANTS WERE PUT IN. ALL OF THE ITEMS ARE STILL IN PATIENT EXCEPT FOR THE CABLES AND CABLE GRIP WHICH WERE REMOVED DURING THIS EVENT.
Patient problems: Insufficient Information
MAUDE report 21263918 ↗InjuryFeb 15, 2022Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth
PATIENT STATED SHE HAD A LEFT THA ON (B)(6) 2016. TWO HOURS AFTER HER SURGERY THE PATIENT WAS BROUGHT BACK TO THE OPERATING ROOM AND WAS TOLD THE PIECE FAILED AND WAS REVISED. PATIENT STATED SHE WAS EXPERIENCING PAIN AND HAVE SEEN HER SURGEON BUT WAS TOLD THAT EVERYTHING WAS FINE. THE PATIENT SOUGHT A SECOND OPINION ON (B)(6) 2018 AND WAS REVISED DUE TO HER X-RAY FINDINGS. PATIENT CONTINUED TO EXPERIENCE PAIN AND WAS REVISED ON (B)(6)2019. PATIENT IS STILL EXPERIENCING EXCRUCIATING PAIN. PATIENT HAS BEEN IN AND OUT OF THE HOSPITAL FOR THE PAST 5 YEARS AND IS SEEKING COMPENSATION FOR ALL HER SUFFERING. THIS PI IS FOR REVISION1. UPDATE ON 21-JAN-2022 BASED ON MED REVIEW: AN OPERATION NOTE ON (B)(6) 2018. THE POSTOPERATIVE DIAGNOSIS WAS "PAINFUL HARDWARE LEFT HIP, REMOVAL OF HARDWARE LEFT HIP, WE ARE REMOVING A CABLE OFF THE FEMUR". NO SIGNS OF INFECTION WERE NOTED A NORMAL AMOUNT OF JOINT FLUID WAS SEEN WITH NO SIGNS OF PURULENCE. FROZEN SECTION CAME BACK NOT CONSISTENT WITH INFECTION. THE CABLE WAS LOOSE AND REMOVED. A REPAIR OF THE ABDUCTOR MECHANISM WAS CARRIED OUT.
Patient problems: Pain
MAUDE report 13539225 ↗
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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