Events

Rappel de SL-PLUS MIA STANDARD

Selon Health Canada (via FOI), ce/cet/cette rappel concerne un dispositif en/au/aux/à Canada qui a été fabriqué par SMITH & NEPHEW INC..

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
    43419
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2016-06-24
  • Pays de l'événement
    Canada
  • Source de l'événement
    HC
  • Notes / Alertes
    Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
  • Notes supplémentaires dans les données
  • Cause
    Smith & nephew inc. has initiated a voluntary field safety corrective action/recall of the ceramic hip prostheses. the current hip prostheses ifus do not provide adequate instruction on the revision surgeries due to ceramic failure. the ifu does not provide the detailed instructions that if a hip prostheses revision is required due to a fractured ceramic component revisions shall only be performed using a ceramic femoral ball head in order to prevent any potential undue wear of the revision components.

Device

SL-PLUS MIA STANDARD
  • Modèle / numéro de série
    Model Catalog: 75001939 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: 75001938 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: 75017194 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: 75017202 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: 75017201 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: 75017200 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: 75017199 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: 75017198 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: 75017197 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: 75017196 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: 75001947 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: 75001946 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: 71500471 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: 71500470 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: 71500469 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: 71500468 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog:
  • Description du dispositif
    SL-PLUS MIA STANDARD;POLARCUP SHELL CEMENTED - S&N;POLARSTEM STANDARD TI-PLASMA/HA SAP #;SL-PLUS MIA LATERAL;SLR-PLUS LATERAL FEMORAL STEMS (S+N);POLARCUP PE X-LINKED INSERT;529750 SL-PLUS LATERAL CEMENTLESS FEMORAL HIP STEM;SL-PLUS INTEGRATION-PLUS MIA S
  • Manufacturer
    SMITH & NEPHEW INC.

Manufacturer

SMITH & NEPHEW INC.