CLASS II Device recall · Reported 25 Mar 2015 · FDA Enforcement Report

Triathlon Distal Capture Assembly recalled

Stryker Howmedica Osteonics is recalling Triathlon Distal Capture Assembly, distributed nationwide in the US. The recall was initiated on 12 Feb 2015 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesER5ND5 ER6EG4 ER5NE4 ER6EG5 ER5NE4M ER6EG5A ER6CG9 ER6KA1 ER6CG9A ER6KA2 ER6CH1 ER6KA3 ER6CH1A ER6KA3A ER6CH1D ER6KA3T ER6CH1M ER6KA4 ER6ED1 ER6KA5 ER6ED1A ER6KA6 ER6ED2 ER6KA7 ER6ED3 ER6KA7T ER6ED4 ER6KA8 ER6ED5 ER6KA8T ER6ED6 ER6KA9 ER6ED7 ER6KD1 ER6ED7E ER6KD2 ER6ED8 ER6KD3 ER6ED8J ER6KD4 ER6ED9 ER6KD5 ER6EE1Y ER6KD6 ER6EE2 ER6KD7 ER6EE6 ER6MA3 ER6EE6M ER6MA4 ER6EE7 ER6SA3 ER6EE7J ER6SA3J ER6EF2 ER6SA3X ER6EF3 ER6SA4 ER6EF3A ER7MA3 ER6EF4 ER7MA3D ER6EF4M ER7MA3M ER6EF5 ER7MA3T ER6EF6 ER7MA4 ER6EF6P ER7MA4A ER6EF8 ER7MA4E ER6EF9 ER7MA4T ER6EG2 ER8SK2 ER6EG3 ER8SK2M ER8SK2P ER8SK3 ER8SK3X ER8SK4 ER8SK4A ER8SK4T ER8WA6 ER8WA6P ER8WA6X ER8WA9 ER8WA9A ER8WA9P ER9CH0 ER9CH0A ER9EA7

Quantity recalled2030 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-1283-2015
FDA event ID: 70341
Recalling firm: Stryker Howmedica Osteonics, Mahwah, NJ
Classification: Class II
Status: Terminated
Recall initiated: 12 Feb 2015
FDA classified: 16 Mar 2015
Reported: 25 Mar 2015
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Lead & Heavy Metals
Device type: Hip & Knee Implants

Timeline

12 Feb 2015	Recall initiated by company
16 Mar 2015	Classified by FDA	+32 days
25 Mar 2015	Published in enforcement report	+9 days

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

Reason for recall

Potential for weld disassociation of the cross pin, which could lead to loose or disassociated trigger mechanism on the Distal Capture Assembly.

Lead and other heavy metals accumulate in the body. Children are most at risk; even low levels can affect development.

Product as listed by the FDA

Triathlon Distal Capture Assembly Catalog No: 6541-1-723 The Triathlon Distal Capture Assembly is used when a surgeon elects to use a capture for the distal femoral resection or proximal tibial resection in a Triathlon primary total knee arthroplasty (TKA).

Where it was distributed

Worldwide Distribution - USA (nationwide) Puerto Rico, and Internationally to Canada, Hong Kong, Netherlands, Sweden, Switzerland, Spain, France, Italy, UK, India, Australia, Korea, Panama, Polan, Ireland, Kuala Lumpar, New Zealand and South Africa.

Nationwide Puerto Rico

Questions about this recall

Is Triathlon Distal Capture Assembly recalled?

Yes. Stryker Howmedica Osteonics recalled Triathlon Distal Capture Assembly on 12 Feb 2015. The recall is Class II and its status is Terminated. Recall number Z-1283-2015.

Why was it recalled?

Potential for weld disassociation of the cross pin, which could lead to loose or disassociated trigger mechanism on the Distal Capture Assembly.

Which lots are affected?

ER5ND5 ER6EG4 ER5NE4 ER6EG5 ER5NE4M ER6EG5A ER6CG9 ER6KA1 ER6CG9A ER6KA2 ER6CH1 ER6KA3 ER6CH1A ER6KA3A ER6CH1D ER6KA3T ER6CH1M ER6KA4 ER6ED1 ER6KA5 ER6ED1A ER6KA6 ER6ED2 ER6KA7 ER6ED3 ER6KA7T ER6ED4 ER6KA8 ER6ED5 ER6KA8T ER6ED6 ER6KA9 ER6ED7 ER6KD1 ER6ED7E ER6KD2 ER6ED8 ER6KD3 ER6ED8J ER6KD4 ER6ED9 ER6KD5 ER6EE1Y ER6KD6 ER6EE2 ER6KD7 ER6EE6 ER6MA3 ER6EE6M ER6MA4 ER6EE7 ER6SA3 ER6EE7J ER6SA3J ER6EF2 ER6SA3X ER6EF3 ER6SA4 ER6EF3A ER7MA3 ER6EF4 ER7MA3D ER6EF4M ER7MA3M ER6EF5 ER7MA3T ER6EF6 ER7MA4 ER6EF6P ER7MA4A ER6EF8 ER7MA4E ER6EF9 ER7MA4T ER6EG2 ER8SK2 ER6EG3 ER8SK2M ER8SK2P ER8SK3 ER8SK3X ER8SK4 ER8SK4A ER8SK4T ER8WA6 ER8WA6P ER8WA6X ER8WA9 ER8WA9A ER8WA9P ER9CH0 ER9CH0A ER9EA7

Where was it sold?

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.

More recalls from Stryker Howmedica Osteonics

All 86

Reported	Class	Recall	Company	Reason	Where
31 May 2017Device	CLASS II	Hoffmann LRF Safety Clip (Bone Transport Strut) recalled	Stryker Howmedica Osteonics	Other	Nationwide
18 Jan 2017Device	CLASS II	Reunion TSA Peg Alignment Sound recalled by Stryker Howmedica Osteonics	Stryker Howmedica Osteonics	Other	Nationwide
28 Dec 2016Device	CLASS II	GAM Kirschner Wire, Sterile R, T2 K-Wire, Sterile R recalled	Stryker Howmedica Osteonics	Sterility	Nationwide
16 Nov 2016Device	CLASS II	LFIT Anatomic V40 Femoral Head, Low Friction Ion Treatment, Sterile recalled	Stryker Howmedica Osteonics	Sterility	Nationwide
19 Oct 2016Device	CLASS II	Stryker Orthopaedics Universal Acetabular Cup Positioner/Impactor recalled	Stryker Howmedica Osteonics	Sterility	Nationwide

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	Nitrosamine Impurity	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)	Lead & Heavy Metals	IN
12 Aug 2026Device	CLASS II	U2 Total Knee System Femoral offset bushing recalled	United Orthopedic	Device Malfunction	Nationwide