Events

Retiro De Equipo (Recall) de Stryker Orthopaedics

Según U.S. Food and Drug Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en United States que fue producido por Stryker Howmedica Osteonics Corp..

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    70994
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1635-2015
  • Fecha de inicio del evento
    2014-08-15
  • Fecha de publicación del evento
    2015-05-19
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2018-01-05
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=135950
  • Notas / Alertas
    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.
  • Notas adicionales en la data
    Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer - Product Code JWH
  • Causa
    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.
  • Acción
    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
  • Modelo / Serial
    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.
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    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.
  • Descripción del producto
    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.
  • Dirección del fabricante
    Stryker Howmedica Osteonics Corp., 325 Corporate Dr, Mahwah NJ 07430-2006
  • Empresa matriz del fabricante (2017)
    Stryker
  • Source
    USFDA