Reported May 27, 2015 · Terminated

Stryker Orthopaedics Triathlon femoral component. Howmedica Osteonics Corp., A subsidiary of Stryker Corporation Made…

Stryker 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: Stryker Howmedica Osteonics Corp. · 325 Corporate Dr · Mahwah, NJ · 07430-2006

Is this the product you have?

  • Stryker Orthopaedics Triathlon femoral component. Howmedica Osteonics Corp., A subsidiary of Stryker Corporation Made in USA Sterile. For use in total reconstructive replacement of the knee joint
Lot codes and dates
  • Item number Lot number 5512-F-201 Lots JYET, KFVZ, KGLX ; 5512-F-202 Lots IPPOP, JYKX, KHZL, KJDN, KJHI, KJKY; 5512-F-301 Lots JTJA, KKAE, KKNB; 5512-F-302 Lots JXXF, KEYD, KFBY, KFTZ, KFXT, KHAB; 5512-F-401 Lots JWGY, KIED; 5512-F-402 Lots IUAJ, JJHT, JOMB, JWPF, JXXM, KGPE, KJMO, KLUP; 5512-F-501 Lots JXMV, KGKP; 5512-F-502 Lots KHWY, KJBK; 5512-F-601 Lots JIML, JIRX, KFAS, KIIY; 5512-F-602 Lots KEXE, KFOS, KFPI, KJAG, KKJW; 5512-F-701 Lot JKTF; 5512-F-801 Lots JWNL, JWPY; 5515-F-301 Lots IVXZD, JEPOD, JHZRA, JITNA, JITND,JJAFD, JJNYA, JJNYD, JKEND, JSNRD, JXBXA, JYFTD, JYGID, JYMTD,JYPJD, KFWHA, KFXID, KGAXD, KGJTD, KGXNA, KIBTA, KIEBA, KIGRD, KIYUD, KJABD, KJISD, KJRID; 5515-F-302 Lots IOLSD, IOLTD, IPRVD, IPTFD, IVGVA, IVLVD, JGIXD, JIGSD, JIYVD, JJSYA, JJWNA, JNVTA, JOWJD, JPFDA, JPHRA, JPIWA, JSZGD, JVYDD, JWPRA, JXBKD, JXOBA, JXXZD, JYBRA, JYBRD, JYKFD, JYKTA, JYMXA, JYNIA, JYNID, JYUED, JZDWD, JZEHD, JZFDD, KFNEA, KFOBA, KFOBD, KFOHD, KFVND, KGMFA, KGMFD, KGWGA, KGZFA, KHBGA, KIEXD, KJBFD, KJDLD, KJFXA, KJFXD, KJNPA, KKJOD; 5515-F-401 Lots JPDRA, JPIXD, JVLND, JVMTD, JXUDD, JYIDD, JYMUD, JZDSA, KABYA, KFDKD, KFMLA, KFPNA, KGAVD, KHEAA, KHKSA, KHZHA, KIATA, KIBVD, KIFMD, KIFOA, KIIFA, KJKBD, KKFYD; 5515-F-402 Lots JIFRD, JIGXD, JIMUD, JIRZD, JKESD, JLVSA, JLWTA, JOUGD, JPFEA, JPGKD, JYEIA, KAJID, KFSND, KGFLD, KGRBA, KGSHD, KGYOD, KJXDD, KKVHA, KLBHD, KLLBD; 5515-F-501 Lots HWHLA, IEXUA, IFDEA, IKEMD, JIAID, JILXA, JJBFD, JJTVD, JKGXD, JOXUA, JPMVD, JZRRA, KFSRA, KGIVD, KGKZA, KGSID, KGVHD, KGVPD, KHGPA, KHKAD, KHWRD, KHXWA, KJGBA, KKHFA, KKHFD, KLOSA; 5515-F-502 Lots IKRKA, JIDLA, JIEZD, JIVTA,JIYYD, JJWSA, JKAAD, JNVJA, JOPDD, JPFBD, JVUAD, JXBYD, JXFLA, JXTRD, JXYSA, JZHAD, JZKTD, KFNGD, KGTLA, KGTMA, KGYFA, KHGVA, KHGVA, KHGVD, KHOFD, KHPLA, KHRTA, KHWMA, KHWVA, KIDPA, KIJDA, KJGLD, KKMDD, KKOOD, KKPKA, KKWAA, KLBZA, KLMBA, KLSFA, KLSFD; 5515-F-601 Lots IPFTA, JIUMD, JJHZA, JMBTA, JWFHD, JWKTA, JXWXA, KABRD, KAGLA, KFISA, KFJXA, KGBVA, KGTDA, KHFSA, KHGNA, KHJAA, KHLIA, KHSWA, KHUAA, KHYED, KHZYA, KIGND, KJKOA; 5515-F-602 Lots JIYHD, JIZOA, JJBWD, JJWPD, JKDPD, JKERA, JPPKD, JJPSXD, JRBRA, JYTBD, KEZND, KFKDA, KFTMD, KFURA, KGIRA, KGNPD, KGRYD, KHJTD, KHPZA, KKXKA, KLKSA.
Amount recalled
1,147 in total

This recall covers 3 products

The agency filed one notice per product. You are reading one of them; the other 2 are below.

Where it was sold

  • Nationwide
  • PR

Why it was recalled

The peel strength of the inner blister may have been below internal validated requirements. The strength of the seal is directly related to long term shelf life of the sterile barrier.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Jan 5, 2018 · Data as of Sep 19, 5:26 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.