Z-2758-2019Class II

TRIATHLON FEMORAL DISTAL AUGMENT 10MM - SIZE 2 RIGHT Catalog # 5541-A-202 -

Name: Z-2758-2019 TRIATHLON FEMORAL DISTAL AUGMENT 10MM - SIZE 2 RIGHT Catalog # 5541-A-202 -
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 RIGHT Catalog # 5541-A-202 - 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-2758-2019
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 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).
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: 171 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# 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2758-2019
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)