CLASS II Device recall · Reported 17 Aug 2016 · FDA Enforcement Report

Stryker Orthopaedics Specialty Triathlon Tibial Alignment recalled

Stryker Howmedica Osteonics is recalling Stryker Orthopaedics Specialty Triathlon Tibial Alignment Handle with Secondary Lock, distributed nationwide in the US. The recall was initiated on 23 Jun 2016 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesCatalog No: I-K3254TA00 Lot Nos: F6E13243, F6L13864, F6M14078, F6S14667, F6S14831, F6W15444, F6W15406, F7C15943, F7H16099 and F7L16994

Quantity recalled47 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-2390-2016
FDA event ID: 74619
Recalling firm: Stryker Howmedica Osteonics, Mahwah, NJ
Classification: Class II
Status: Terminated
Recall initiated: 23 Jun 2016
FDA classified: 11 Aug 2016
Reported: 17 Aug 2016
Type: Voluntary: Firm initiated
Customers notified by: E-Mail
Reason category: Other Reasons
Device type: Hip & Knee Implants

Timeline

23 Jun 2016	Recall initiated by company
11 Aug 2016	Classified by FDA	+49 days
17 Aug 2016	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

It was reported that the secondary locking mechanism, and its corresponding components, disassociated from the Specialty Triathlon Tibial Alignment Handle with Secondary Lock Assembly during surgery. Upon further investigation, it was discovered that the weld, which was intended to hold the secondary locking mechanism together, did not meet the weld size specified on the engineering drawing.

Product as listed by the FDA

Stryker Orthopaedics Specialty Triathlon Tibial Alignment Handle with Secondary Lock, Non-Sterile, Used to complement or replace the standard instruments used during the implantation of hip, knee, trauma and upper extremities implants

Where it was distributed

Nationwide Distribution to FL, IN, LA, NC, PA, TN and UT

Nationwide Florida Indiana Louisiana North Carolina Pennsylvania Tennessee Utah

Questions about this recall

Why was it recalled?

Which lots are affected?

Catalog No: I-K3254TA00 Lot Nos: F6E13243, F6L13864, F6M14078, F6S14667, F6S14831, F6W15444, F6W15406, F7C15943, F7H16099 and F7L16994

Where was it sold?

Nationwide Distribution to FL, IN, LA, NC, PA, TN and UT

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.

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All 86

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31 May 2017Device	CLASS II	Hoffmann LRF Safety Clip (Bone Transport Strut) recalled	Stryker Howmedica Osteonics	Other	Nationwide
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All 3,111

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14 Oct 2026Device	CLASS II	Intellijoint Navigation System: Workstation G2 Configured recalled	Intellijoint Surgical	Device Malfunction	Nationwide
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23 Sep 2026Device	CLASS II	Axle Pin Assy Large Elbow Cobalt Chrome recalled by Howmedica Osteonics	Howmedica Osteonics	Other	Nationwide
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23 Sep 2026Device	CLASS II	Scorpio Recessed Metal Backed Patella 3045 recalled	Howmedica Osteonics	Foreign Material	Nationwide