CLASS II Device recall · Reported 9 Oct 2019 · FDA Enforcement Report

Triathlon Femoral Distal Augment - Size 2 Right recalled

Howmedica Osteonics is recalling Triathlon Femoral Distal Augment - Size 2 Right, distributed nationwide in the US. The recall was initiated on 19 Aug 2019 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesAll lots with an expiration date on or before 31 June 2024. Lot# A3E7R A3H9I A7A9A A9U7R AB37T AB74U ABB7S AE49B AES9B AGAR AGAS AGB3E AGT4E AGV3G AH37L AIO4V AO74U AOD9I ARO9B ASV7B ATA9R ATY3T AU99O AUX7R AY33Z AYO4V BAA4S BAB7Y BAH3D BAI7D BBE4R BBL4Y BDZ9H BER7H BH97L BLY9D BO77U BRR9H BRT7Z BSI4X BTD9B DGFR DGPY DNUW DOFW DRFR DRPA DYEK DYRN EDHL FNYJ FOGV FVVR FYST FYTP GFPG GJMG GJNM GYOD GYVG GZNA GZRT GZWG GZWS HHXY HHZF HHZZ HIBF HUPS HVBW HYHG HYJB IBTS IBTW IEVY ILAX ILBL INJO INNB INNE IUWT IVAB IYLR JBYI JFGV JFNZ JHDR JIKH JILH JNIX JVEZ JZSI KFYW KHHJ KHNX KHSO KMEX KSPV KVRZ KVVS KWPV KYND KZYB MEDM MFZX MGLY MLBP MMFV NEBU S3HS SOBP SPO4 SR4E TGGA TIYY TPPH TPTI UHIP USLI UT3I UZDD V4AH VA3Y VBGT VGGG VJHG VJYO VPBW VPYA VT43 VUWT VVJG VW3E WGRG WO4G WOYL WPJT WRXC WRYC WSDE WVWI WVWJ WXAV WXAW XAVX XAVY XDYL XDYM XGDX XGDY XIJC XKSY XKSZ XOCL XOCM XTJY XTJZ XVIO XVIP XWVK XWVM XYGP XYGR YBCC YBCD YESI YFJX YFJY YG3H YGSJ YGSK

Quantity recalled171 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-2758-2019
FDA event ID: 83671
Recalling firm: Howmedica Osteonics, Mahwah, NJ
Classification: Class II
Status: Terminated
Recall initiated: 19 Aug 2019
FDA classified: 27 Sep 2019
Reported: 9 Oct 2019
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Hip & Knee Implants

Timeline

19 Aug 2019	Recall initiated by company
27 Sep 2019	Classified by FDA	+39 days
9 Oct 2019	Published in enforcement report	+12 days

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

Reason for recall

Due to device overhang issue that protrudes beyond the medial periphery of the mating femoral component

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

TRIATHLON FEMORAL DISTAL AUGMENT 10MM - SIZE 2 RIGHT Catalog # 5541-A-202 - Product Usage: Triathlon Femoral Distal Augments are used with Triathlon TS Femoral Components during revision Total Knee Arthroplasty (TKA) and with Triathlon Primary PS Femoral Components during TKA to address distal femoral defects. (See attached IFU (IFU_Triathlon Total Knee_QIN 4376 Rev AB).

Where it was distributed

Worldwide distribution - US Nationwide distribution including the states of AL,AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY, and countries of Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Columbia, Denmark, Finland, France, Germany, Honk Kong, India, Ireland, Iran, Italy, Israel, Japan, Kazakhstan, Korea, Kuwait, Malaysia, Mexico, Netherlands, New Zealand, Norway, Poland, Portugal, Puerto Rico, Romania, Russia, Saudi Arabia, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, and UK.

Nationwide Alabama Arkansas Arizona California Colorado Connecticut District of Columbia Delaware Florida Georgia Hawaii Iowa Idaho Illinois Indiana Kansas Kentucky Louisiana Massachusetts Maryland

Questions about this recall

Why was it recalled?

Due to device overhang issue that protrudes beyond the medial periphery of the mating femoral component

Which lots are affected?

All lots with an expiration date on or before 31 June 2024. Lot# A3E7R A3H9I A7A9A A9U7R AB37T AB74U ABB7S AE49B AES9B AGAR AGAS AGB3E AGT4E AGV3G AH37L AIO4V AO74U AOD9I ARO9B ASV7B ATA9R ATY3T AU99O AUX7R AY33Z AYO4V BAA4S BAB7Y BAH3D BAI7D BBE4R BBL4Y BDZ9H BER7H BH97L BLY9D BO77U BRR9H BRT7Z BSI4X BTD9B DGFR DGPY DNUW DOFW DRFR DRPA DYEK DYRN EDHL FNYJ FOGV FVVR FYST FYTP GFPG GJMG GJNM GYOD GYVG GZNA GZRT GZWG GZWS HHXY HHZF HHZZ HIBF HUPS HVBW HYHG HYJB IBTS IBTW IEVY ILAX ILBL INJO INNB INNE IUWT IVAB IYLR JBYI JFGV JFNZ JHDR JIKH JILH JNIX JVEZ JZSI KFYW KHHJ KHNX KHSO KMEX KSPV KVRZ KVVS KWPV KYND KZYB MEDM MFZX MGLY MLBP MMFV NEBU S3HS SOBP SPO4 SR4E TGGA TIYY TPPH TPTI UHIP USLI UT3I UZDD V4AH VA3Y VBGT VGGG VJHG VJYO VPBW VPYA VT43 VUWT VVJG VW3E WGRG WO4G WOYL WPJT WRXC WRYC WSDE WVWI WVWJ WXAV WXAW XAVX XAVY XDYL XDYM XGDX XGDY XIJC XKSY XKSZ XOCL XOCM XTJY XTJZ XVIO XVIP XWVK XWVM XYGP XYGR YBCC YBCD YESI YFJX YFJY YG3H YGSJ YGSK

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 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

3 other products · FDA event 83671

This product is part of a recall event; the main page for the event is Triathlon Femoral Distal Augment - Size 2 Right recalled.

Reported	Class	Recall	Company	Reason	Where
9 Oct 2019	CLASS II	Triathlon Femoral Distal Augment - Size 2 Right recalled	Howmedica Osteonics	Device Malfunction	Nationwide
9 Oct 2019	CLASS II	Triathlon Femoral Distal Augment recalled by Howmedica Osteonics	Howmedica Osteonics	Device Malfunction	Nationwide
9 Oct 2019	CLASS II	Triathlon Femoral Distal Augment - Size 2 Left recalled	Howmedica Osteonics	Device Malfunction	Nationwide

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