URGENT! RAPPEL PRODUIT Dispositifs Médicaux stériles - Implants

Transcription

1 To A l attention de : Directeur CLMV Pharmacien SB0 Fax : From Anne-Sophie PINON Fax If you do not receive the fax in full, please contact us at the telephone number above Date : 9 août 2012 Time Pages : 13 Subject : Rappel de produit URGENT! RAPPEL PRODUIT Dispositifs Médicaux stériles - Implants Madame, Monsieur, Smith & Nephew procède au rappel des ancres des gammes BIORAPTOR, FOOTPRINT PK, FOOTPRINT Ultra, HEALICOIL, TWINFIX Ti, TWINFIX PK, TWINFIX Ultra Ti, TWINFIX Ultra PK et TWINFIX Quick-T, références suivantes (tous lots confondus) : Référence Description Page 1 sur 13

2 mm BIORAPTOR CURVED PK Suture Anchor, with one ULTRABRAID (#2) Suture (COBRAID -black) 2.3 mm BIORAPTOR CURVED PK Suture Anchor, with one ULTRABRAID (#2) Suture (COBRAID-blue) mm BIORAPTOR Knotless Suture Anchor mm BIORAPTOR Knotless Suture Anchor mm BIORAPTOR PK Suture Anchor with one ULTRABRAID #2 (COBRAID-blue) suture, mm BIORAPTOR PK Suture Anchor with one ULTRABRAID #2 (COBRAID-black), suture mm BIORAPTOR PK Suture Anchor with one ULTRABRAID #2 (white) suture, mm HEALICOIL PK Suture Anchor with two ULTRABRAID (#2) Sutures (blue, COBRAID-blue), suture mm HEALICOIL PK Suture Anchor with two ULTRABRAID (#2) Sutures (blue, COBRAID-blue), mm HEALICOIL PK Suture Anchor with three ULTRABRAID (#2) Sutures (blue, COBRAID-blue, COBRAID-black), mm FOOTPRINT Ultra Suture Anchor mm FOOTPRINT PK Suture Anchor with disposable awl mm FOOTPRINT PK Suture Anchor with disposable awl mm FOOTPRINT PK Suture Anchor Page 2 sur 13

3 mm FOOTPRINT PK Suture Anchor mm FOOTPRINT Ultra Suture Anchor mm TWINFIX Ti with 2 DURABRAID Sutures Size mm TWINFIX Ti Suture Anchor with two #2 preloaded DURABRAID sutures, mm TWINFIX Ultra PK Anchor with two #2 sutures (white, COBRAIDblue), mm TWINFIX Ultra PK Anchor with two #2 sutures (COBRAID-blue, COBRAID-black), mm TWINFIX Ultra PK Anchor with two #2 sutures (blue, COBRAID blue), mm TWINFIX Ultra PK Anchor with two #2 sutures (white, COBRAID-blue), mm TWINFIX Ultra PK Anchor with two #2 sutures (COBRAID-blue, COBRAID-black), mm TWINFIX Ultra PK Anchor with three #2 sutures (white, COBRAID-blue, COBRAID-black), mm TWINFIX Ultra PK Anchor with two #2 sutures (blue, COBRAIDblue), mm TWINFIX Ultra PK Anchor with two #2 suture (white, COBRAIDblue), mm TWINFIX Ultra PK Anchor with two #2 sutures (COBRAID-blue, COBRAID-black), Page 3 sur 13

4 mm TWINFIX Ultra PK Anchor with three #2 sutures (white, COBRAID-blue, COBRAID-black), mm TWINFIX Ultra PK Anchor with two #2 sutures (blue, COBRAIDblue), mm TWINFIX Ultra Ti Anchor with two #2 sutures (white, COBRAIDblue), mm TWINFIX Ultra Ti Anchor with two #2 sutures (COBRAID-blue, COBRAID-black), mm TWINFIX Ultra Ti Anchor with two #2 sutures (white, COBRAIDblue), mm TWINFIX Ultra Ti Anchor with two #2 sutures (COBRAID-blue, COBRAID-black), mm TWINFIX Ultra Ti Anchor with three #2 sutures (white, COBRAID-blue, COBRAID-black), mm TWINFIX Ultra Ti Anchor with two #2 sutures (white, COBRAID-blue), mm TWINFIX Ultra Ti Anchor with two #2 sutures (COBRAID-blue, COBRAID-black), mm TWINFIX Ultra Ti Anchor with three #2 sutures (white, COBRAID-blue, COBRAID-black) mm TWINFIX PK FT Anchor with two #2 sutures (COBRAID-blue, white ULTRABRAID ), mm TWINFIX PK FT Anchor with two #2 sutures (COBRAID-blue, white ULTRABRAID),, with awl mm TWINFIX PK FT Anchor with two #2 sutures (COBRAID-blue, white ULTRABRAID), Page 4 sur 13

5 mm TWINFIX PK FT Anchor with two #2 suture (COBRAID-blue, white ULTRABRAID), with awl mm TWINFIX PK FT Anchor with three #2 sutures (white, COBRAID-blue, COBRAID-black), mm TWINFIX PK FT Anchor with three #2 sutures (white, COBRAID-blue, COBRAID-black), with awl mm TWINFIX PK FT Anchor with three #2 sutures (white, COBRAID blue, COBRAID-black), mm TWINFIX PK FT Anchor with three #2 sutures (white, COBRAID-blue, COBRAID-black),, with awl mm TWINFIX PK FT Anchor with two #2 sutures (COBRAID-blue, COBRAID-black) mm TWINFIX PK FT Anchor with two #2 sutures (COBRAID-blue, COBRAID-black), with awl mm TWINFIX PK FT Anchor with two #2 sutures (COBRAID-blue, COBRAID-black) mm TWINFIX Ti Suture Anchor with two #2 preloaded DURABRAID sutures, mm TWINFIX Ti Suture Anchor with two #2 preloaded DURABRAID sutures, mm TWINFIX Ti Suture Anchor with two #2 preloaded ULTRABRAID sutures, mm TWINFIX Ti Suture Anchor with two #2 preloaded ULTRABRAID sutures, mm TWINFIX Ti Suture Anchor with two #2 preloaded ULTRABRAID sutures, Anchor Pack (3 per a box) Page 5 sur 13

6 mm TWINFIX Ti Quick-T Fixation System, mm TWINFIX Ti Quick-T Fixation System, mm TWINFIX Quick-T implant with Quick-T Knot Pusher and Suture Cutter, mm TWINFIX Quick-T implant Quick-T Knot Pusher and Suture Cutter, mm TWINFIX Ti Suture Anchor with two #2 preloaded ULTRABRAID mm TWINFIX Ti Suture Anchor with two #2 preloaded ULTRABRAID (3 per a box) sutures,, Suture Anchor Pack mm TWINFIX Ti Suture Anchor with one #2 preloaded ULTRABRAID (3 per a box) suture,, Suture Anchor Pack mm TWINFIX Ti Suture Anchor with one #2 preloaded DURABRAID suture, mm TWINFIX Ti Suture Anchor with one #1 preloaded DURABRAID suture, mm TWINFIX Ti Suture Anchor with one #2 preloaded ULTRABRAID suture, Ce rappel est motivé par le motif suivant : présence éventuelle de micro-perforations dans certains sachets pouvant compromettre la stérilité du produit. Nos enregistrements indiquent que des produits concernés par ce rappel ont été livrés à votre établissement. Nous vous demandons : INSTRUCTIONS Page 6 sur 13

7 1. d identifier tous les produits comportant les références mentionnées ci-dessus, présents au sein de votre établissement et de les placer en quarantaine sans délai. 2. de nous faxer au à l attention d Anne-Sophie PINON, Département des Affaires Réglementaires, la fiche récapitulative de stock ci-jointe complétée, dans un délai maximum de 7 jours. Dans le cas où vous n auriez plus aucun produit à retourner, merci de compléter cette fiche et de nous la faxer en cochant la case «Nous n avons pas de produits concernés par le rappel». A réception de notre formulaire complété, nous procéderons aussitôt à la reprise des produits par un transporteur ainsi qu à l échange des produits dans la mesure du possible. En cas de besoin, vous pouvez contacter votre chargé de clientèle habituel ou joindre le service clients au Nous vous prions de bien vouloir nous excuser pour la gêne occasionnée par ce rappel de produit et vous remercions de l attention que vous porterez à notre demande. Nous vous prions d agréer, Madame, Monsieur, l expression de nos sincères salutations. Anne-Sophie PINON Pharmacien Responsable Affaires Réglementaires Tél: Fax: [email protected] Page 7 sur 13

8 Fiche récapitulative de stock CLIENT N Compte client : Nom Adresse Téléphone Fax Référence Désignation produit 2.3 mm BIORAPTOR CURVED PK Suture Anchor, with one ULTRABRAID (#2) Suture (COBRAID -black) Quantité à faire reprendre* mm BIORAPTOR CURVED PK Suture Anchor, with one ULTRABRAID (#2) Suture (COBRAID-blue) mm BIORAPTOR Knotless Suture Anchor mm BIORAPTOR Knotless Suture Anchor mm BIORAPTOR PK Suture Anchor with one ULTRABRAID #2 (COBRAID-blue) suture, mm BIORAPTOR PK Suture Anchor with one ULTRABRAID #2 (COBRAID-black), suture mm BIORAPTOR PK Suture Anchor with one ULTRABRAID #2 (white) suture, mm HEALICOIL PK Suture Anchor with two ULTRABRAID (#2) Sutures (blue, COBRAID-blue), suture mm HEALICOIL PK Suture Anchor with two ULTRABRAID (#2) Sutures (blue, COBRAID-blue), mm HEALICOIL PK Suture Anchor with three ULTRABRAID (#2) Sutures (blue, COBRAID-blue, COBRAID-black), mm FOOTPRINT Ultra Suture Anchor mm FOOTPRINT PK Suture Anchor with disposable awl Page 8 sur 13

9 Fiche récapitulative de stock mm FOOTPRINT PK Suture Anchor with disposable awl mm FOOTPRINT PK Suture Anchor mm FOOTPRINT PK Suture Anchor mm FOOTPRINT Ultra Suture Anchor mm TWINFIX Ti with 2 DURABRAID Sutures Size mm TWINFIX Ti Suture Anchor with two #2 preloaded DURABRAID sutures, mm TWINFIX Ultra PK Anchor with two #2 sutures (white, COBRAID-blue), mm TWINFIX Ultra PK Anchor with two #2 sutures (COBRAID-blue, COBRAID-black), mm TWINFIX Ultra PK Anchor with two #2 sutures (blue, COBRAID -blue), mm TWINFIX Ultra PK Anchor with two #2 sutures (white, COBRAID-blue), mm TWINFIX Ultra PK Anchor with two #2 sutures (COBRAID-blue, COBRAID-black), mm TWINFIX Ultra PK Anchor with three #2 sutures (white, COBRAID-blue, COBRAID-black), mm TWINFIX Ultra PK Anchor with two #2 sutures (blue, COBRAID-blue), mm TWINFIX Ultra PK Anchor with two #2 suture (white, COBRAID-blue), mm TWINFIX Ultra PK Anchor with two #2 sutures (COBRAID-blue, COBRAID-black), mm TWINFIX Ultra PK Anchor with three #2 sutures (white, COBRAID-blue, COBRAID-black), mm TWINFIX Ultra PK Anchor with two #2 sutures (blue, COBRAID-blue), Page 9 sur 13

10 Fiche récapitulative de stock mm TWINFIX Ultra Ti Anchor with two #2 sutures (white, COBRAID-blue), mm TWINFIX Ultra Ti Anchor with two #2 sutures (COBRAID-blue, COBRAID-black), mm TWINFIX Ultra Ti Anchor with two #2 sutures (white, COBRAID-blue), mm TWINFIX Ultra Ti Anchor with two #2 sutures (COBRAID-blue, COBRAID-black), mm TWINFIX Ultra Ti Anchor with three #2 sutures (white, COBRAID-blue, COBRAID-black), mm TWINFIX Ultra Ti Anchor with two #2 sutures (white, COBRAID-blue), mm TWINFIX Ultra Ti Anchor with two #2 sutures (COBRAID-blue, COBRAID-black), mm TWINFIX Ultra Ti Anchor with three #2 sutures (white, COBRAID-blue, COBRAID-black) mm TWINFIX PK FT Anchor with two #2 sutures (COBRAID-blue, white ULTRABRAID ), mm TWINFIX PK FT Anchor with two #2 sutures (COBRAID-blue, white ULTRABRAID),, with awl mm TWINFIX PK FT Anchor with two #2 sutures (COBRAID-blue, white ULTRABRAID), mm TWINFIX PK FT Anchor with two #2 suture (COBRAID-blue, white ULTRABRAID), with awl mm TWINFIX PK FT Anchor with three #2 sutures (white, COBRAID-blue, COBRAID-black), mm TWINFIX PK FT Anchor with three #2 sutures (white, COBRAID-blue, COBRAID-black), with awl mm TWINFIX PK FT Anchor with three #2 sutures (white, COBRAID -blue, COBRAID-black), Page 10 sur 13

11 Fiche récapitulative de stock mm TWINFIX PK FT Anchor with three #2 sutures (white, COBRAID-blue, COBRAID-black),, with awl mm TWINFIX PK FT Anchor with two #2 sutures (COBRAID-blue, COBRAID-black) mm TWINFIX PK FT Anchor with two #2 sutures (COBRAID-blue, COBRAID-black), with awl mm TWINFIX PK FT Anchor with two #2 sutures (COBRAID-blue, COBRAID-black) mm TWINFIX Ti Suture Anchor with two #2 preloaded DURABRAID sutures, mm TWINFIX Ti Suture Anchor with two #2 preloaded DURABRAID sutures, mm TWINFIX Ti Suture Anchor with two #2 preloaded ULTRABRAID sutures, mm TWINFIX Ti Suture Anchor with two #2 preloaded ULTRABRAID sutures, mm TWINFIX Ti Suture Anchor with two #2 preloaded ULTRABRAID sutures, Anchor Pack (3 per a box) mm TWINFIX Ti Quick-T Fixation System, mm TWINFIX Ti Quick-T Fixation System, mm TWINFIX Quick-T implant with Quick-T Knot Pusher and Suture Cutter, mm TWINFIX Quick-T implant Quick-T Knot Pusher and Suture Cutter, mm TWINFIX Ti Suture Anchor with two #2 preloaded ULTRABRAID mm TWINFIX Ti Suture Anchor with two #2 preloaded ULTRABRAID (3 per a box) sutures,, Suture Anchor Pack mm TWINFIX Ti Suture Anchor with one #2 preloaded ULTRABRAID (3 per a box) suture,, Suture Anchor Pack Page 11 sur 13

12 Fiche récapitulative de stock mm TWINFIX Ti Suture Anchor with one #2 preloaded DURABRAID suture, mm TWINFIX Ti Suture Anchor with one #1 preloaded DURABRAID suture, mm TWINFIX Ti Suture Anchor with one #2 preloaded ULTRABRAID suture, Page 12 sur 13

13 Fiche récapitulative de stock Nous n avons pas de produits concernés par le rappel (cocher la case). La personne soussignée reconnaît avoir été informée du rappel des produits et avoir recherché tous les produits concernés : Ancres des gammes BIORAPTOR, FOOTPRINT PK, FOOTPRINT Ultra, HEALICOIL, TWINFIX Ti, TWINFIX PK, TWINFIX Ultra Ti, TWINFIX Ultra PK et TWINFIX Quick-T (réf ci-dessus) dans l établissement et le cas échéant dans les établissements à qui elle a livré ces produits. * Lieu d enlèvement des produits par le transporteur : Nom et n de tél de la pers. à contacter pour la reprise : Date de disponibilité des colis : Nombre de colis : Horaires d ouverture : Horaires de fermeture : Nom : N de tél. Fonction : Signature : Date : Cachet de l établissement : Formulaire à compléter et à retourner par fax à Smith & Nephew SAS Département Affaires Réglementaires Anne-Sophie PINON - Fax : Page 13 sur 13