CLASS II ONGOING Device recall · Reported 21 Oct 2026 · FDA Enforcement Report

TS Misc. Instruments Tray, Triathlon recalled by Howmedica Osteonics

Howmedica Osteonics is recalling TS Misc. Instruments Tray, Triathlon. The recall was initiated on 16 Sep 2026 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesCatalog Number: 6543-6-519. GTIN: 07613327555127. All lot numbers used prior to the correction date of May 8, 2026 are impacted.

Quantity recalled577 trays

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-0167-2027
FDA event ID: 99883
Recalling firm: Howmedica Osteonics, Mahwah, NJ
Classification: Class II
Status: Ongoing
Recall initiated: 16 Sep 2026
FDA classified: 15 Oct 2026
Reported: 21 Oct 2026
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Sterility
Device type: Other Medical Devices

Timeline

16 Sep 2026	Recall initiated by company
15 Oct 2026	Classified by FDA	+29 days
21 Oct 2026	Published in enforcement report	+6 days

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

Reason for recall

Reprocessing instructions provided in LSTPI-B specify a sterilization dry time of 30 minutes for the trays sterilized in blue wrap. When blue wrap is used, the 30-minute dry time may lead to a small amount of residual moisture remaining after sterilization.

A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.

Product as listed by the FDA

TS Misc. Instruments Tray, Triathlon. Catalog Number: 6543-6-519.

Where it was distributed

These trays are provided by sale or loan. Loans are provided through Distributor. Foreign Consignees will be identified by the countries impacted. 158 trays have been distributed OUS.

Questions about this recall

Why was it recalled?

Which lots are affected?

Catalog Number: 6543-6-519. GTIN: 07613327555127. All lot numbers used prior to the correction date of May 8, 2026 are impacted.

Where was it sold?

These trays are provided by sale or loan. Loans are provided through Distributor. Foreign Consignees will be identified by the countries impacted. 158 trays have been distributed OUS.

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 27 Oct 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

3 other products · FDA event 99883

This product is part of a recall event; the main page for the event is TS Universal Baseplate Finishing Tray, Triathlon recalled.

Reported	Class	Recall	Company	Reason	Where
21 Oct 2026	CLASS II	TS Universal Baseplate Finishing Tray, Triathlon recalled	Howmedica Osteonics	Sterility	NJ
21 Oct 2026	CLASS II	Triathlon Hinge Femoral Prep Tray recalled by Howmedica Osteonics	Howmedica Osteonics	Sterility	NJ
21 Oct 2026	CLASS II	TS Femoral Prep Tray, Triathlon recalled by Howmedica Osteonics	Howmedica Osteonics	Sterility	NJ

More recalls from Howmedica Osteonics

All 248

Reported	Class	Recall	Company	Reason	Where
21 Oct 2026Device	CLASS II	TS Femoral Prep Tray, Triathlon recalled by Howmedica Osteonics	Howmedica Osteonics	Sterility	NJ
21 Oct 2026Device	CLASS II	Triathlon Hinge Femoral Prep Tray recalled by Howmedica Osteonics	Howmedica Osteonics	Sterility	NJ
21 Oct 2026Device	CLASS II	TS Universal Baseplate Finishing Tray, Triathlon recalled	Howmedica Osteonics	Sterility	NJ
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

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