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

Triathlon Femoral Distal Augment - Size 2 Left recalled

Howmedica Osteonics is recalling Triathlon Femoral Distal Augment - Size 2 Left, 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 # A3A4G A3O4G A7E4A A7S7Y AABP AABR AAS7L ABI3L ABY7A AE44H AEB7H AER7Y AGS7H AHS4D AIA7Y AII4Z ALR4L AOU3R ARG9T ASZ3O ATG4X ATU7D AVG7Z AVO9H AYG9Y AYX3Y BAE3E BAU3L BE93T BEB4L BGU4G BHL9O BIE7H BL74I BLL9A BRE9E BRO7U BRY4Y BS97E BSH7H BSO3G BTE4D DNVL DRSG DVXW DZKF FUXX FVAH GARO GAWP GBTP GJZD GKAJ GKDW GLAN GLBU GLHI GLHY HHRP HHVI HXGO HXML HXUV HYHY HZBN HZKZ HZNH IBSA IBZA IDZV IKGT IKKM ILHJ INIM INLE ITMY IXNB IYRK JBOV JDJY JEUD JIOX JIYT JJZE JKFX JKYF JLIF JOJF JWEF JWVL JYWU JZYF KEXO KMFK KMGH KMIS KOHJ KPNX KRPW KSNI KUZR KVYS MDZU MLWL MNKY MOHT MPNI MROZ S3HR SSVR TGOB U3BV ULIO USUR UZYY V4ZD VADL VGLG VHWH VJHI VJYL VPSZ VRDA VTYL VWRZ VZVT WDVE WIRA WISA WOTL WOUL WRUR WRUS WVZO WWEP WXTS WXTT WXTU WZP3 XEMZ XENA XHZU XKWY XKWZ XLRY XLRZ XSFN XSFP XSZE XSZF XVJA XVKZ XWVJ XWWZ XYGU XYGV YBJJ YBJK YCZR YCZS YFXP YFXR YGDI YGDZ YHDM YHDN

Quantity recalled167 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-2757-2019
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 LEFT Catalog # 5541-A-201 - 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 # A3A4G A3O4G A7E4A A7S7Y AABP AABR AAS7L ABI3L ABY7A AE44H AEB7H AER7Y AGS7H AHS4D AIA7Y AII4Z ALR4L AOU3R ARG9T ASZ3O ATG4X ATU7D AVG7Z AVO9H AYG9Y AYX3Y BAE3E BAU3L BE93T BEB4L BGU4G BHL9O BIE7H BL74I BLL9A BRE9E BRO7U BRY4Y BS97E BSH7H BSO3G BTE4D DNVL DRSG DVXW DZKF FUXX FVAH GARO GAWP GBTP GJZD GKAJ GKDW GLAN GLBU GLHI GLHY HHRP HHVI HXGO HXML HXUV HYHY HZBN HZKZ HZNH IBSA IBZA IDZV IKGT IKKM ILHJ INIM INLE ITMY IXNB IYRK JBOV JDJY JEUD JIOX JIYT JJZE JKFX JKYF JLIF JOJF JWEF JWVL JYWU JZYF KEXO KMFK KMGH KMIS KOHJ KPNX KRPW KSNI KUZR KVYS MDZU MLWL MNKY MOHT MPNI MROZ S3HR SSVR TGOB U3BV ULIO USUR UZYY V4ZD VADL VGLG VHWH VJHI VJYL VPSZ VRDA VTYL VWRZ VZVT WDVE WIRA WISA WOTL WOUL WRUR WRUS WVZO WWEP WXTS WXTT WXTU WZP3 XEMZ XENA XHZU XKWY XKWZ XLRY XLRZ XSFN XSFP XSZE XSZF XVJA XVKZ XWVJ XWWZ XYGU XYGV YBJJ YBJK YCZR YCZS YFXP YFXR YGDI YGDZ YHDM YHDN

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 Right recalled	Howmedica Osteonics	Device Malfunction	Nationwide

More recalls from Howmedica Osteonics

All 232

Reported	Class	Recall	Company	Reason	Where
24 Jun 2026Device	CLASS II	Tri Ts Baseplate Size recalled by Howmedica Osteonics	Howmedica Osteonics	Packaging Defects	Nationwide
24 Jun 2026Device	CLASS II	Tri Ts Baseplate Size recalled by Howmedica Osteonics	Howmedica Osteonics	Packaging Defects	Nationwide
25 Mar 2026Device	CLASS II	MICS3 Angled Sagittal Saw Attachment recalled by Howmedica Osteonics	Howmedica Osteonics	Other	Nationwide
31 Dec 2025Device	CLASS II	The Stryker CranialMask Tracker is a single-use device recalled	Howmedica Osteonics	Device Malfunction	Nationwide
8 Oct 2025Device	CLASS II	Exeter V40 Stem No recalled by Howmedica Osteonics	Howmedica Osteonics	Packaging Defects	NJ

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	Device Malfunction	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)	Other	IN
12 Aug 2026Device	CLASS II	U2 Total Knee System Femoral offset bushing recalled	United Orthopedic	Device Malfunction	Nationwide