Reported Oct 9, 2019 · Terminated
TRIATHLON FEMORAL DISTAL AUGMENT 10MM - SIZE 2 RIGHT Catalog # 5541-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 10MM - SIZE 2 RIGHT Catalog # 5541-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#AGAR AGAS
A3E7RA3H9IA7A9AA9U7RAB37TAB74UABB7SAE49BAES9B
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 YGSKAGB3EAGT4EAGV3GAH37LAIO4VAO74UAOD9IARO9BASV7BATA9RATY3TAU99OAUX7RAY33ZAYO4VBAA4SBAB7YBAH3DBAI7DBBE4RBBL4YBDZ9HBER7HBH97LBLY9DBO77UBRR9HBRT7ZBSI4XBTD9B
- All lots with an expiration date on or before 31 June 2024. Lot#
- Amount recalled
- 171 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.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new Howmedica Osteonics Corp. recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.