Reported Oct 9, 2019 · Terminated
TRIATHLON FEMORAL DISTAL AUGMENT 15MM - SIZE 2 RIGHT Catalog # 5542-A-202 - Product Usage: Triathlon Femoral Distal…
Howmedica Osteonics Corp.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Howmedica Osteonics Corp. · 325 Corporate Dr · Mahwah, NJ · 07430-2006
Is this the product you have?
- TRIATHLON FEMORAL DISTAL AUGMENT 15MM - SIZE 2 RIGHT Catalog # 5542-A-202 -
- Product UsageTriathlon 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)
- Lot codes and dates
- All lots with an expiration date on or before 31 June 2024. Lot#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
A3G9IA3L3EA494UA737RA7O3VA9Z9IAB34VAEU3AAEV4TAGT3GAGU9HAH73UAHE9AALS7RAOG7LARD3SASS9SASU7HATY7ZAXZ3GAY37SBAS4ABBX7RBDV9HBEL3LBEZ3GBG34HBGL3YBLZ4VBO49DBOA3BBOX9GBRG9OBRV7ABRY9VBSR7EBSS4BBTB3H
- All lots with an expiration date on or before 31 June 2024. Lot#
- Amount recalled
- 159 units
This recall covers 4 products
The agency filed one notice per product. You are reading one of them; the other 3 are below.
Where it was sold
Why it was recalled
Due to device overhang issue that protrudes beyond the medial periphery of the mating femoral component
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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