Reported Oct 9, 2019 · Terminated
TRIATHLON FEMORAL DISTAL AUGMENT 15MM - SIZE 2 LEFTTriathlon Femoral Distal Augments are used with Triathlon TS Femoral…
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 LEFTTriathlon 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) Catalog # 5542-A-201 -
- Product Usage—
- Lot codes and dates
- All lots with an expiration date on or before 31 June 2024. Lot #DFHS DFOR DGFY DGJN DNNS DPSK GEZU GFBA GFWO GGID GISR GITX GLDE GLEK GLFE GYKA GZYI GZZO HVFF HYZB HZAP HZFF HZRR IDGA IDXJ IEYN IJPT IKJU IRIK ISIR IULX IWXH IZXM JAAE JFWD JFYR JHWV JJDF JLGH JMEP JPFR JTXL JUEV KFSH KGWZ KIDM KIFY KION KJYX KMKE KPKD KWXS KZDA LARN LBMI MDIF MMUR S3O3 S3OP ST3Y STHI STUE TAOV TARO TGLR UDYZ UUZT UWHB VEU4 VJKA VJLN VVKR VVMJ VW4Y VYAY WHOP WINY WIVT WOOU WPGU WRZZ WVWK WVWL WXAC WXAF XBEL XBEM XDXI XDXJ XIAR XIAS XKLP XKLR XMXO XMXP XMXR XSFR XSFS XVMV XVMW XVNF XVNG XWVH XWVI XYUX XYVJ YA3U YAIL YAIM YCFT YCFV YFUX YFUY YGIC YGID YHLN YHLO
A3I7LA4A7BA4V7DA7G7HA7H4UA7L4VA7V3UA9X4SA9Y3VAAG7RABU3YAEE3AAEU9YAGT4RAGV3SALS3VAOG3TAOX9LASD3TATT7DAV34SAYA3BAZB4RAZE9GBAE4XBAX4ABBG4XBDR7TBDZ4DBE37YBGE4VBHE7XBIG4LBR79TBRU7OBSR4R
- All lots with an expiration date on or before 31 June 2024. Lot #
- Amount recalled
- 153 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.