CLASS II ONGOING Device recall · Reported 23 Sep 2026 · FDA Enforcement Report

Triathlon Hinge Insert Size 4 5612-p-411 Triathlon Hinge recalled

Howmedica Osteonics is recalling Triathlon Hinge Insert Size 4 5612-p-411 Triathlon Hinge Insert Size 4 5612-p-413, distributed nationwide in the US. The recall was initiated on 30 Jul 2026 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codes5612-P-411 UDI-DI 07613327601893 Lot 360958 5612-P-413 UDI-DI 07613327602012 Lot 354573

Quantity recalled12,156 US

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-3198-2026
FDA event ID: 99558
Recalling firm: Howmedica Osteonics, Mahwah, NJ
Classification: Class II
Status: Ongoing
Recall initiated: 30 Jul 2026
FDA classified: 16 Sep 2026
Reported: 23 Sep 2026
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Hip & Knee Implants

Timeline

30 Jul 2026	Recall initiated by company
16 Sep 2026	Classified by FDA	+48 days
23 Sep 2026	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw material aged in excess of five years. Product has the potential for elevated levels of oxidation, which may result in increased wear, leading to hazards such as excessive wear debris, material fragments, fractured device, or disassociated device. Potential harms include revision surgery, pain, and inflammation.

Product as listed by the FDA

TRIATHLON HINGE INSERT SIZE 4 11MM 5612-P-411 TRIATHLON HINGE INSERT SIZE 4 13MM 5612-P-413 Orthopaedic implant components manufactured from UHMWPE (polyethylene)

Where it was distributed

Worldwide distribution - US Nationwide and the countries of Canada, LATAM, Europe, Asia Pacific, and South Africa.

Nationwide

Questions about this recall

Why was it recalled?

Which lots are affected?

5612-P-411 UDI-DI 07613327601893 Lot 360958 5612-P-413 UDI-DI 07613327602012 Lot 354573

Where was it sold?

Worldwide distribution - US Nationwide and the countries of Canada, LATAM, Europe, Asia Pacific, and South Africa.

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 29 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

11 other products · FDA event 99558

This product is part of a recall event; the main page for the event is Scorpio C-dome Patella 73-2710 73-2910 Scorpio U-dome recalled.

Reported	Class	Recall	Company	Reason	Where
23 Sep 2026	CLASS II	Scorpio C-dome Patella 73-2710 73-2910 Scorpio U-dome recalled	Howmedica Osteonics	Other	Nationwide
23 Sep 2026	CLASS II	Abg I Acetabular Insert Hooded Id C-m079-2-801 Arc2f recalled	Howmedica Osteonics	Other	Nationwide
23 Sep 2026	CLASS II	Acetabular Cup Uhmwpe 61-3258 All Poly Constrained Insert recalled	Howmedica Osteonics	Other	Nationwide
23 Sep 2026	CLASS II	Omnifit Series I Acet recalled by Howmedica Osteonics	Howmedica Osteonics	Other	Nationwide
23 Sep 2026	CLASS II	Trident 0¿ Poly Insert ID 620-00-28D Orthopaedic implant recalled	Howmedica Osteonics	Other	Nationwide
23 Sep 2026	CLASS II	All Poly Constrained Insert 69-2854 Nrg Knee Cr recalled	Howmedica Osteonics	Other	Nationwide
23 Sep 2026	CLASS II	Duracon XL Angled Tib Ins C-m064-1-300 Self-pressurizing recalled	Howmedica Osteonics	Other	Nationwide
23 Sep 2026	CLASS II	Scorpio + Mobile Bearing Pcs 78-5-0910 System One Bipolar recalled	Howmedica Osteonics	Other	Nationwide
23 Sep 2026	CLASS II	Bearing And Axle Bushing Assy Std Elbow C-m113-1-301 Krh recalled	Howmedica Osteonics	Other	Nationwide
23 Sep 2026	CLASS II	Scorpio Recessed Metal Backed Patella 3045 recalled	Howmedica Osteonics	Foreign Material	Nationwide
23 Sep 2026	CLASS II	Axle Pin Assy Large Elbow Cobalt Chrome recalled by Howmedica Osteonics	Howmedica Osteonics	Other	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	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
23 Sep 2026Device	CLASS II	Duracon XL Angled Tib Ins C-m064-1-300 Self-pressurizing recalled	Howmedica Osteonics	Other	Nationwide

Other Hip & Knee Implants recalls

All 3,109

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	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
23 Sep 2026Device	CLASS II	Duracon XL Angled Tib Ins C-m064-1-300 Self-pressurizing recalled	Howmedica Osteonics	Other	Nationwide