CLASS II ONGOING Device recall · Reported 13 Mar 2024 · FDA Enforcement Report

No 3 Triathlon Ts Plus Tib Ins X3 Poly recalled by Howmedica Osteonics

Howmedica Osteonics is recalling No 3 Triathlon Ts Plus Tib Ins X3 Poly, distributed nationwide in the US. The recall was initiated on 6 Feb 2024 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesPart No. 5537-G-311-E; GTIN: 07613327288063; Lot No. EP81Y7, YL5VKA; Expiration Date: 10/07/2028.

Quantity recalled39 units (US); 10 units (OUS)

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-1263-2024
FDA event ID: 94026
Recalling firm: Howmedica Osteonics, Mahwah, NJ
Classification: Class II
Status: Ongoing
Recall initiated: 6 Feb 2024
FDA classified: 6 Mar 2024
Reported: 13 Mar 2024
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Sterility
Device type: Other Medical Devices

Timeline

6 Feb 2024	Recall initiated by company
6 Mar 2024	Classified by FDA	+29 days
13 Mar 2024	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

Potential packaging breaches of inner blister and outer sterile blister.

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

NO 3 TRIATHLON TS PLUS TIB INS X3 POLY 11 MM

Where it was distributed

Domestic: Nationwide Distribution; Foreign: Australia, Canada, Chile, Colombia, Korea, & Japan.

Nationwide

Questions about this recall

Is No 3 Triathlon Ts Plus Tib Ins X3 Poly recalled?

Yes. Howmedica Osteonics recalled No 3 Triathlon Ts Plus Tib Ins X3 Poly on 6 Feb 2024. The recall is Class II and its status is Ongoing. Recall number Z-1263-2024.

Why was it recalled?

Potential packaging breaches of inner blister and outer sterile blister.

Which lots are affected?

Part No. 5537-G-311-E; GTIN: 07613327288063; Lot No. EP81Y7, YL5VKA; Expiration Date: 10/07/2028.

Where was it sold?

Domestic: Nationwide Distribution; Foreign: Australia, Canada, Chile, Colombia, Korea, & 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 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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