Z-2759-2019Class II

TRIATHLON FEMORAL DISTAL AUGMENT 15MM - SIZE 2 LEFTTriathlon Femoral Distal Augments are used with Triathlon...

Name: Z-2759-2019 TRIATHLON FEMORAL DISTAL AUGMENT 15MM - SIZE 2 LEFTTriathlon Femoral Distal Augments are used with Triathlon...
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 15MM - SIZE 2 LEFTTriathlon Femoral Distal Augments are used with Triathlon TS Femoral Components during revision Total Knee... 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-2759-2019
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 15MM - SIZE 2 LEFTTriathlon 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) Catalog # 5542-A-201 - Product Usage:
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: 153 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 # A3I7L A4A7B A4V7D A7G7H A7H4U A7L4V A7V3U A9X4S A9Y3V AAG7R ABU3Y AEE3A AEU9Y AGT4R AGV3S ALS3V AOG3T AOX9L ASD3T ATT7D AV34S AYA3B AZB4R AZE9G BAE4X BAX4A BBG4X BDR7T BDZ4D BE37Y BGE4V BHE7X BIG4L BR79T BRU7O BSR4R DFHS DFOR DGFY DGJN DNNS DPSK GEZU GFBA GFWO GGID GISR GITX GLDE GLEK GLFE GYKA GZYI GZZO HVFF HYZB HZAP HZFF HZRR IDGA IDXJ IEYN IJPT IKJU IRIK ISIR IULX IWXH IZXM JAAE JFWD JFYR JHWV JJDF JLGH JMEP JPFR JTXL JUEV KFSH KGWZ KIDM KIFY KION KJYX KMKE KPKD KWXS KZDA LARN LBMI MDIF MMUR S3O3 S3OP ST3Y STHI STUE TAOV TARO TGLR UDYZ UUZT UWHB VEU4 VJKA VJLN VVKR VVMJ VW4Y VYAY WHOP WINY WIVT WOOU WPGU WRZZ WVWK WVWL WXAC WXAF XBEL XBEM XDXI XDXJ XIAR XIAS XKLP XKLR XMXO XMXP XMXR XSFR XSFS XVMV XVMW XVNF XVNG XWVH XWVI XYUX XYVJ YA3U YAIL YAIM YCFT YCFV YFUX YFUY YGIC YGID YHLN YHLO

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2759-2019
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)