CLASS II ONGOING Device recall · Reported 24 Jul 2024 · FDA Enforcement Report
Unitrax Endoprosthesis Head Component recalled by Howmedica Osteonics
Howmedica Osteonics is recalling Unitrax Endoprosthesis Head Component - Implantable component used in partial hip, distributed nationwide in the US. The recall was initiated on 19 Jun 2024 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2371-2024
- FDA event ID
- 94871
- Recalling firm
- Howmedica Osteonics, Mahwah, NJ
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 19 Jun 2024
- FDA classified
- 16 Jul 2024
- Reported
- 24 Jul 2024
- Type
- Voluntary: Firm initiated
- Reason category
- Labeling Errors
- Device type
- Hip & Knee Implants
Timeline
| 19 Jun 2024 | Recall initiated by company | |
| 16 Jul 2024 | Classified by FDA | +27 days |
| 24 Jul 2024 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Mislabeled: the size on the package label of the UNITRAX¿ Endoprosthesis Head Component potentially may not match the device within the packaging. This product mix only involves the three (3) sizes (43mm, 42mm, and the 38mm)
Product as listed by the FDA
UNITRAX Endoprosthesis Head Component - 42mm. Implantable component used in partial hip arthroplasty. Catalog Number: 6942-5-042
Where it was distributed
Worldwide distribution - US Nationwide and the countries of Australia, Hong Kong, and UK.
Questions about this recall
Why was it recalled?
Mislabeled: the size on the package label of the UNITRAX¿ Endoprosthesis Head Component potentially may not match the device within the packaging. This product mix only involves the three (3) sizes (43mm, 42mm, and the 38mm)
Which lots are affected?
GTIN: 07613327032369 Lot Numbers: 4615EX, HE645D, 8A399N
Where was it sold?
Worldwide distribution - US Nationwide and the countries of Australia, Hong Kong, and UK.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
2 other products · FDA event 94871This product is part of a recall event; the main page for the event is Unitrax Endoprosthesis Head Component recalled by Howmedica Osteonics.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Unitrax Endoprosthesis Head Component recalled by Howmedica Osteonics | Howmedica Osteonics | Labeling Errors | Nationwide | |
| CLASS II | Unitrax Endoprosthesis Head Component recalled by Howmedica Osteonics | Howmedica Osteonics | Labeling Errors | Nationwide |
More recalls from Howmedica Osteonics
All 248| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | TS Misc. Instruments Tray, Triathlon recalled by Howmedica Osteonics | Howmedica Osteonics | Sterility | NJ |
| Device | CLASS II | TS Femoral Prep Tray, Triathlon recalled by Howmedica Osteonics | Howmedica Osteonics | Sterility | NJ |
| Device | CLASS II | Triathlon Hinge Femoral Prep Tray recalled by Howmedica Osteonics | Howmedica Osteonics | Sterility | NJ |
| Device | CLASS II | TS Universal Baseplate Finishing Tray, Triathlon recalled | Howmedica Osteonics | Sterility | NJ |
| Device | CLASS II | Axle Pin Assy Large Elbow Cobalt Chrome recalled by Howmedica Osteonics | Howmedica Osteonics | Other | Nationwide |
Other Hip & Knee Implants recalls
All 3,118| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Halyard Anterior Hip Pack recalled by Avid Medical | Avid Medical | Sterility | Nationwide |
| Device | CLASS II | Halyard Anterior Hip Pack recalled by Avid Medical | Avid Medical | Sterility | Nationwide |
| Device | CLASS II | Medline medical convenience kits labeled as: Hip Scope Pack recalled | Medline Industries | Other | Nationwide |
| Device | CLASS II | TS Femoral Prep Tray, Triathlon recalled by Howmedica Osteonics | Howmedica Osteonics | Sterility | NJ |
| Device | CLASS II | Grafton" DBM and Grafton Plus" DBM contain demineralized recalled | Medtronic Sofamor Danek USA | Other Bacterial Contamination | Nationwide |