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Recall Observatory FDA recall evidence

Device product

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

Z-1635-2015

August 15, 2014

Class II

Product summary

Firm
Stryker Howmedica Osteonics Corp.
Event
Event 70994
Status
Terminated
Classification
Class II
Quantity
1,147 in total
Official record key
device-enforcement:Z-1635-2015

Official wording

Reason: 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.

Code information: 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.

Distribution pattern: Worldwide Distribution: US (nationwide) including PR and countries of: Australia, Canada, China, Brazil, France, Hong Kong, India, Italy, Mexico, Netherlands, Singapore, South Africa, Sweden, and Spain.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.