medical Class II Updated 2019-10-09

Howmedica Osteonics Corp. recalls TRIATHLON FEMORAL DISTAL AUGMENT 10MM - SIZE 2 RIGHT Catalo

Recalled 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).

Hazard / Issue

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

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: 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
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