Events

Rappel de Stryker Orthopaedics

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par Stryker Howmedica Osteonics Corp..

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    70994
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1635-2015
  • Date de mise en oeuvre de l'événement
    2014-08-15
  • Date de publication de l'événement
    2015-05-19
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2018-01-05
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=135950
  • Notes / Alertes
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notes supplémentaires dans les données
    Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer - Product Code JWH
  • Cause
    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.
  • Action
    The firm, Stryker Orthopaedics, notified their Branches/Agencies via email on 8/15/2014 and sent an "Urgent Product Recall" letter dated 8/15/2014 with a Product Recall Acknowledgement Forms to their Branches/Agencies and consignees. The letter describes the product, issue, potential hazards and actions to be taken. The consignees were instructed to complete and return the attached Product Recall Acknowledgment Form within 5 days via fax to 855-251-3635; and return the affected product to the attention of Regulatory Compliance, Stryker Orthopaedics, 325 Corporate Drive, Mahwah NJ 07430. If you have any questions, feel free to contact Sr. Regulatory Compliance Specialist to 201-831-5826.

Device

Stryker Orthopaedics
  • Modèle / numéro de série
    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.
  • Classification du dispositif
    Orthopedic Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    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.
  • Description du dispositif
    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
  • Manufacturer
    Stryker Howmedica Osteonics Corp.

Manufacturer

Stryker Howmedica Osteonics Corp.
  • Adresse du fabricant
    Stryker Howmedica Osteonics Corp., 325 Corporate Dr, Mahwah NJ 07430-2006
  • Société-mère du fabricant (2017)
    Stryker
  • Source
    USFDA