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

Lot, batch or date codesGTIN: 07613327032369 Lot Numbers: 4615EX, HE645D, 8A399N

Quantity recalled18 units

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.

Nationwide

Questions about this recall

Why was it recalled?

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 94871

This 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
24 Jul 2024	CLASS II	Unitrax Endoprosthesis Head Component recalled by Howmedica Osteonics	Howmedica Osteonics	Labeling Errors	Nationwide
24 Jul 2024	CLASS II	Unitrax Endoprosthesis Head Component recalled by Howmedica Osteonics	Howmedica Osteonics	Labeling Errors	Nationwide

More recalls from Howmedica Osteonics

All 244

Reported	Class	Recall	Company	Reason	Where
23 Sep 2026Device	CLASS II	Axle Pin Assy Large Elbow Cobalt Chrome recalled by Howmedica Osteonics	Howmedica Osteonics	Other	Nationwide
23 Sep 2026Device	CLASS II	Triathlon Hinge Insert Size 4 5612-p-411 Triathlon Hinge recalled	Howmedica Osteonics	Other	Nationwide
23 Sep 2026Device	CLASS II	Scorpio Recessed Metal Backed Patella 3045 recalled	Howmedica Osteonics	Foreign Material	Nationwide
23 Sep 2026Device	CLASS II	Bearing And Axle Bushing Assy Std Elbow C-m113-1-301 Krh recalled	Howmedica Osteonics	Other	Nationwide
23 Sep 2026Device	CLASS II	Scorpio + Mobile Bearing Pcs 78-5-0910 System One Bipolar recalled	Howmedica Osteonics	Other	Nationwide

Other Hip & Knee Implants recalls

All 3,110

Reported	Class	Recall	Company	Reason	Where
30 Sep 2026Device	CLASS II	Trinity Non-Surgical Isolation Gown, AAMI PB70 Level 2, X-Large recalled	New York Embroidery Studio	Packaging Defects	Nationwide
23 Sep 2026Device	CLASS II	Axle Pin Assy Large Elbow Cobalt Chrome recalled by Howmedica Osteonics	Howmedica Osteonics	Other	Nationwide
23 Sep 2026Device	CLASS II	Triathlon Hinge Insert Size 4 5612-p-411 Triathlon Hinge recalled	Howmedica Osteonics	Other	Nationwide
23 Sep 2026Device	CLASS II	Scorpio Recessed Metal Backed Patella 3045 recalled	Howmedica Osteonics	Foreign Material	Nationwide
23 Sep 2026Device	CLASS II	Bearing And Axle Bushing Assy Std Elbow C-m113-1-301 Krh recalled	Howmedica Osteonics	Other	Nationwide