medical Class II Updated 2019-10-09

Howmedica Osteonics Corp. recalls TRIATHLON FEMORAL DISTAL AUGMENT 15MM - SIZE 2 RIGHT Catalo

Recalled Product

TRIATHLON FEMORAL DISTAL AUGMENT 15MM - SIZE 2 RIGHT Catalog # 5542-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# A3G9I A3L3E A494U A737R A7O3V A9Z9I AB34V AEU3A AEV4T AGT3G AGU9H AH73U AHE9A ALS7R AOG7L ARD3S ASS9S ASU7H ATY7Z AXZ3G AY37S BAS4A BBX7R BDV9H BEL3L BEZ3G BG34H BGL3Y BLZ4V BO49D BOA3B BOX9G BRG9O BRV7A BRY9V BSR7E BSS4B BTB3H DGKJ DGSH DIXP DKAX FYPO FYRV GFMT GJLZ GJNG GLDO GZJM GZNW GZSO GZTX GZXN GZXP HUTX HWPK HXYV IBPA IBPG IDXU IKKL IKUD IMUI ISHW IXVN IYSN IZUI JBSB JBXN JHAF JHGV JJFK JORA JUWH JZWG KDER KDZP KEOH KFXJ KGSW KJEK KJHN KKPN KLXZ KSGD KSPF KTLH KUAI KUKW KYBZ LBAM LBFD MBZM MDBV MERR MFSR MIRW MMLL SZSR TROU TRVH UEYI UHER UZIY VETP VJMC VJOS VUWS VVCY VVDW WHDY WISW WIWZ WRTS WRXX WTDT WVVP WVZC WXBU WXBV WXBW WXPH WXPI WXPJ XBEH XBEI XDBP XDBR XIJA XKIW XKIX XNAC XNBF XNCN XRBV XRBW XTAS XTAT XVHZ XVMM XVMN XVNA XXIW XXIX XYHM XYHN YBDF YBDG YCEY YCEZ YCZV YCZW YFCI YFCJ YGJM YGJN YHHU YHPT YHPU
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