Unitrax 6942-6-070Recalls & reported problems
Howmedica Osteonics Corp. · Neck Adjustment Sleeve · Class 2 · Implant
All models of Unitrax (20)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07613327013429), received between Aug 8, 2019 and Aug 8, 2019 — classified as 1 malfunction.
The most frequently reported specific device problem is “Device Difficult to Setup or Prepare” (1 report).
2 other recalls cover devices cleared under the same FDA submission (K173499, K954077); 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 18, 2026.
Most reported problems
Device problems
- Device Difficult to Setup or Prepare1
Patient problems
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 8, 2019Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare
PRIMARY PROCEDURE, LEFT HIP HEMIARTHROPLASTY, DIRECT ANTERIOR APPROACH. IT WAS REPORTED THAT THE SLEEVE WAS ASSEMBLED IN THE UNITRAX HEAD AND BROUGHT TO THE SURGEON. WHEN THE SURGEON TURNED THE CONSTRUCT OVER TO IMPLANT IT, THE SLEEVE FELL OUT. THE SLEEVE WAS RE-INSERTED INTO THE HEAD AND THE CONSTRUCT WAS IMPACTED ON THE STEM. THE CONSTRUCT WOULD NOT LOCK. THE CONSTRUCT WAS BROUGHT TO THE BACK TABLE AND ANOTHER HEAD/SLEEVE CONSTRUCT (SAME CATALOG NUMBER, DIFFERENT LOT NUMBER) WAS USED AND PERFORMED AS EXPECTED. SURGERY WAS COMPLETED SUCCESSFULLY WITH A DELAY OF APPROXIMATELY 5 MINUTES. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE AVAILABLE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8873366 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K173499, K954077. One submission often covers many models, so check the product and lot details in each record.
- Z-0314-2022 · Oct 15, 2021 · Open, Classified28MM -4 LFIT V40 HEAD, Catalog Number 6260-9-122
- Z-0313-2022 · Oct 15, 2021 · Open, Classified28MM -4 LFIT V40 HEAD, Catalog Number 6260-9-028
Other Prosthesis, hip, hemi-, femoral, metal devices
- UHR UH1-48-28Howmedica Osteonics Corp. · Prosthesis, hip, hemi-, femoral, metal2 recalls3 reports
- "UNITED" USTAR II Knee System 2515-3111United Orthopedic Corp. · Prosthesis, Hip, Hemi-, Femoral, Metal2 recalls0 reports
- "UNITED" USTAR II Knee System 2515-3213United Orthopedic Corp. · Prosthesis, Hip, Hemi-, Femoral, Metal2 recalls0 reports
- STAGEONE 431207Biomet Orthopedics, LLC · Prosthesis, hip, hemi-, femoral, metal2 recalls0 reports
- "UNITED" USTAR II Knee System 2515-3115United Orthopedic Corp. · Prosthesis, Hip, Hemi-, Femoral, Metal2 recalls0 reports
- ACTIS 101011050Depuy (Ireland) · Prosthesis, hip, hemi-, femoral, metal73 reports
- UHR UH1-46-26Howmedica Osteonics Corp. · Prosthesis, hip, hemi-, femoral, metal1 recall11 reports
- UHR UH1-45-26Howmedica Osteonics Corp. · Prosthesis, hip, hemi-, femoral, metal1 recall11 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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