Events

Retiro De Equipo (Recall) de Device Recall Stryker Recon, Radial Implant, Standard Stem

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
    71676
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2429-2015
  • Fecha de inicio del evento
    2015-06-24
  • Fecha de publicación del evento
    2015-08-20
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2016-04-29
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=138752
  • 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, elbow, semi-constrained, cemented - Product Code JDB
  • Causa
    Stryker is recalling rhead, uhead, sigmoid notch, remotion, radio capitellum because packaging integrity (sterile barrier) of the packaging type kit i may potentially be compromised by transportation.
  • Acción
    Branches/Agencies were notified by Stryker of this action by e-mails on June 24, 2015 and an Urgent Medical Device Removal Letter/Acknowledgement Response Form dated June 25, 2015 was sent to the attention of the Risk Manager.

Device

Device Recall Stryker Recon, Radial Implant, Standard Stem
  • Modelo / Serial
    Part Number: RCN-S1 (#1 Bipolar Stem Implant - Sterile packed) - Lot #'s 18566, 18567, 18568, 18697, 18837, 22297901, 22297902, 22848901, 19099-S2, 19101-S2, 19684-S2, 19685-S2, 19716-S2, 19769-S2, 19803-S2, 19846-S2, 19918-S2, 19919-S2 and 19982-S2; Part Number: RCN-S2 (#2 Bipolar Stem Implant - Sterile packed) - Lot #'s 18295, 18753, 18839, 22098402, 22298001, 22298002, 22614201, 22614202, 22849101, 23068301, 19664-S2, 19718-S2, 19719-S2, 19770-S2, 19771-S2, 19772-S2, 19805-S2, 19847-S2, 19848-S2, 19849-S2, 19850-S2 and 19921-S2; Part Number: RCN-S3 (#3 Bipolar Stem Implant - Sterile packed) - Lot #'s 18296, 18754, 22298101, 22298102, 22614401, 22614402, 22849301, 23068501, 23068502, 23479701, 19665-S2, 19720-S2, 19721-S2, 19722-S2, 19774-S2, 19775-S2, 19776-S2, 19806-S2, 19852-S2, 19853-S2 and R237901; Part Number: RCN-S4 (#4 Bipolar Stem Implant - Sterile packed) - Lot #'s 18885, 18886, 22298201, 22298202, 22614501, 22614502, 22849501, 23068601, 23479901, 19666-S2, 19724-S2, 19725-S2, 19777-S2, 19808-S2, 19855-S2, 19856-S2, 19922-S2, 19988-S2 and R23479901  Part Number: RHA-S1 (Radial Stem Implant #1 - Sterile packed) - Lot #'s 18374, 18387, 18500, 18574, 18705, 18706, 18845, 18846, 18847, 22613001, 22850001, 23069001, 19111-S2, 19112-S2, 19726-S2, 19778-S2 and 19857-S2; Part Number: RHA-S2 (Radial Stem Implant #2 - Sterile packed) - Lot #'s 22098802, 22279401, 22279402, 22613201, 22850201, 23069201, 23493402, 109667-S2, 19780-S2 19781-S2, 19810-S2, 19859-S2, 19860-S2, 19861-S2, 19923-S2 and R23493402;  Part Number: RHA-S3 (Radial Stem Implant #3 - Sterile packed) - Lot #'s 18855, 22098902, 22279501, 22279502, 22613401, 22613402, 22850401, 23069401, 23226201, 23490201, 19687-S2, 19727-S2, 19728-S2, 19729-S2, 19783-S2, 19811-S2, 19812-S2, 19862-S2, 19863-S2, 19924-S2, 19925-S2 and R23490201;  Part Number: RHA-S4 (Radial Stem Implant #4 - Sterile packed) - Lot #'s 18378, 22279601, 22613601, 22613602, 22850601, 23069501, 23226301, 23491501, 19668-S2, 19784-S2, 19814-S2, 19864-S2, 19926-S2, 19927-S2 and R23491501;  Part Number: WA/C-L (Wrist Carpal Implant Large) - Lot #'s 23689901, 23946601, 23946602, 23946603, 24056601 and 19064-S2;  Part Number: WA/C-M (Wrist Carpal Implant Medium) - Lot #'s 22296901, 22296902, 22595501, 22595502, 22758401, 22758402, 23041201, 23216201, 23689801, 23689802, 23689803, 23946801, 23946802, 23946803, 24056701, 24056702 and 24056703;  Part Number: WA/C-S (Wrist Carpal Implant Small) - Lot #'s 22297001, 22297002, 22431101, 22595601, 225965602, 22758501, 22758502, 23041301, 23689701, 23689702, 23689703, 23946701, 23946702, 23946703, 24056801, 24056802 and 24056803;  Part Number: WA/R-LL (Wrist Left Radial Implant Large) - Lot #'s 18872, 23946901, 23946902, 23946903, 24056901, 19061-S2, 19605-S2, 19828-S2, 19829-S2, 19955-S2, R19605-S2, R19828-S2 and R19829-S2;  Part Number: WA/R-LM (Wrist Left Radial Implant Medium) - Lot #'s 22595701, 22758601, 22758602, 23041401, 23690401, 23690401, 23690402, 23690403, 24057001, 19062-S2, R23690401, R23690402 and R23690403;  Part Number: WA/R-LS (Wrist Left Radial Implant Small) - Lot #'s 22758701, 22758702, 23041501, 23216301, 23690501, 23690502, 24057101, 24057102, R23690501 and R23690502;  Part Number: WA/R-LXS (Distal Radial Comp X-Small, Left, Sterile) - Lot #'s 18794, 18873, 22758801, 22758802 and 23041601;  Part Number: WA/R-RL (Wrist Right Radial Implant Large) - Lot #'s 18795, 23690001, 23690002, 23690003, 24057201, R23690001, R23690002 and R23690003;  Part Number: WA/R-RM (Wrist Right Radial Implant Medium) - Lot #'s 15892, 22297101, 22595801, 22758901, 22758902, 23041701, 23261401, 23690101, 23690102, 23690103, 23947101, 23947102, 24057301, R23690101 and R23690102;  Part Number: WA/R-Rs (Wrist Right Radial Implant Small) - Lot #'s 22297201, 22595901, 22595901, 22595902, 22759001, 22759002, 23041801, 23261501, 23690201, 23690202, 23690203, 23947001, 23947002, 23947003, 23947004, 24057401, 19073-S2, R23690201 and R23690202;  Part Number: WA/R-RXS (Distal Radial Comp X-Small, Right, Sterile) - Lot #'s 18796, 18874, 22596001, 22759101, 22759102, 23041901, 23690301, 23690302, 23690303, 23947201, 24057501, R23690301, R23690302 and R23690303.
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Worldwide Distribution.
  • Descripción del producto
    Recon, Radial Implant, Standard Stem, Size 1, Sterile, Do Not Reuse, Rx Only. Intended for replacement of the proximal end of the radius.
  • 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