Z-2757-2019Class II

TRIATHLON FEMORAL DISTAL AUGMENT 10MM - SIZE 2 LEFT Catalog # 5541-A-201 -

Name: Z-2757-2019 TRIATHLON FEMORAL DISTAL AUGMENT 10MM - SIZE 2 LEFT Catalog # 5541-A-201 -
Creator: Howmedica Osteonics Corp.
Published: 2019-08-19
License: https://open.fda.gov/license/

Howmedica Osteonics Corp / initiated 2019-08-19 / Terminated / root cause: design

FDA source

Howmedica Osteonics Corp. began a recall of TRIATHLON FEMORAL DISTAL AUGMENT 10MM - SIZE 2 LEFT Catalog # 5541-A-201 - Product Usage: Triathlon Femoral Distal Augments are used with Triathlon TS Femoral... on 2019-08-19. FDA classified it as Class II and gives the reason as "Due to device overhang issue that protrudes beyond the medial periphery of the mating femoral component". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-2757-2019
Classification: Class II
Status: Terminated
Initiated: 2019-08-19
Posted: 2019-09-27
Terminated: 2020-05-06
Recalling firm: Howmedica Osteonics Corp
Product: 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).
Product code: MBH Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
Reason for recall: Due to device overhang issue that protrudes beyond the medial periphery of the mating femoral component
Root cause tag: design
FDA root cause: Device Design
Action: 1. Inform users of this Urgent Medical Device Recall and forward this notice to all those individuals who need to be aware within your organization. 2. Immediately check all stock areas and/or operating room storage to determine if any devices from the affected product list are at your facility. 3. Quarantine and discontinue use of the recalled devices. 4. Complete and sign the enclosed Urgent Medical Device Recall Business Reply Form and fax a copy to 1-877-551-7148 or email to [email protected]. 5. Return all affected instruments available at your location to the following address. Stryker Orthopaedics/PFA Product Returns Attn: Distribution Inventory Team 325 Corporate Drive Dock M-East Mahwah, NJ 07430 Ref. PFA 2144473
Quantity in commerce: 167 units
Distribution: 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.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2757-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2757-2019	Class II	Terminated	Voluntary: Firm initiated	2019-10-09	2019-09-27
Z-2758-2019	Class II	Terminated	Voluntary: Firm initiated	2019-10-09	2019-09-27
Z-2759-2019	Class II	Terminated	Voluntary: Firm initiated	2019-10-09	2019-09-27
Z-2760-2019	Class II	Terminated	Voluntary: Firm initiated	2019-10-09	2019-09-27

Product code MBH

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)