CLASS II ONGOING Device recall · Reported 7 Jun 2023 · FDA Enforcement Report

Triathlon X3 Tibial Bearing Insert CS #3-Intended recalled

Howmedica Osteonics is recalling Triathlon X3 Tibial Bearing Insert CS #3-Intended for knee replacement, distributed nationwide in the US. The recall was initiated on 13 Apr 2023 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesGTIN: 07613327390698 Lot Number: JH3AHJ

Quantity recalled24 units in total

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-1653-2023
FDA event ID: 92257
Recalling firm: Howmedica Osteonics, Mahwah, NJ
Classification: Class II
Status: Ongoing
Recall initiated: 13 Apr 2023
FDA classified: 30 May 2023
Reported: 7 Jun 2023
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Labeling Errors
Device type: Hip & Knee Implants

Timeline

13 Apr 2023	Recall initiated by company
30 May 2023	Classified by FDA	+47 days
7 Jun 2023	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:Labeled Catalog Number: 5531-G-312-E, TRIATHLON X3 TIBIAL BEARING INSERT CS #3 12MM, may contain Catalog Number: 5532-G-413-E, TRIATHLON X3 TIBIAL BEARING INSERT PS #4 13MM, and vice versa

Product as listed by the FDA

TRIATHLON X3 TIBIAL BEARING INSERT CS #3 12MM-Intended for knee replacement Catalog Number: 5531-G-312-E

Where it was distributed

US Nationwide - Worldwide Distribution: CT, FL, IN, KY, MT, NJ, OR, PA, SC Foreign: China, Japan

Nationwide Connecticut Florida Indiana Kentucky Montana New Jersey Oregon Pennsylvania South Carolina

Questions about this recall

Why was it recalled?

Mislabeled:Labeled Catalog Number: 5531-G-312-E, TRIATHLON X3 TIBIAL BEARING INSERT CS #3 12MM, may contain Catalog Number: 5532-G-413-E, TRIATHLON X3 TIBIAL BEARING INSERT PS #4 13MM, and vice versa

Which lots are affected?

GTIN: 07613327390698 Lot Number: JH3AHJ

Where was it sold?

US Nationwide - Worldwide Distribution: CT, FL, IN, KY, MT, NJ, OR, PA, SC Foreign: China, Japan

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

1 other product · FDA event 92257

This product is part of a recall event; the main page for the event is Triathlon X3 Tibial Bearing Insert PS #4 Intended recalled.

Reported	Class	Recall	Company	Reason	Where
7 Jun 2023	CLASS II	Triathlon X3 Tibial Bearing Insert PS #4 Intended recalled	Howmedica Osteonics	Labeling Errors	Nationwide

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Other Hip & Knee Implants recalls

All 3,097

Reported	Class	Recall	Company	Reason	Where
2 Sep 2026Device	CLASS II	Medline convenience kits labeled as: Femoral Pack, Medline Kit recalled	Medline Industries	Other	Nationwide
26 Aug 2026Device	CLASS II	Arvis Surgical Navigation System Gen recalled by Kico Knee Innovation	Kico Knee Innovation	Device Malfunction	19 states
26 Aug 2026Device	CLASS II	Veritas Standard Reverse Total Shoulder Veritas Standard recalled	restor3d	Device Malfunction	Nationwide
19 Aug 2026Device	CLASS II	Endo-Model, Replacement Set, Tibial Plateau, right/left, L, Uhmwpe recalled	Waldemar Link GmbH & Co. KG (Mfg Site)	Other	IN
12 Aug 2026Device	CLASS II	U2 Total Knee System Femoral offset bushing recalled	United Orthopedic	Device Malfunction	Nationwide