Events

Rappel de Device Recall CrossCHECK Locking Screw

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 Wright Medical Technology, 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
    71895
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2542-2015
  • Date de mise en oeuvre de l'événement
    2015-07-21
  • Date de publication de l'événement
    2015-09-01
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2018-08-01
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=139288
  • 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
    Plate, fixation, bone - Product Code HRS
  • Cause
    These screws have a potential of passing through the plate in the case when torque is applied in excessive amounts, which may result in intraoperative malfunction.
  • Action
    Wright sent an Urgent Medical Device Recall letter dated July 20, 2015, to all affected customers. Customers were asked to complete the attached response form confirming receipt of the notice and the status of any products on hand, and return a copy to Wright by email (complaints@wmt.com or fax (901)867-7401. Also, if customers have any product in their inventory the product should be sent back to Arlington, TN (ALM). For questions regarding this recall call 901-290-5662.

Device

Device Recall CrossCHECK Locking Screw
  • Modèle / numéro de série
    CrossCHECK Non-Locking Screw with the following codes: REF CCP-N3008: Lot Numbers: 34996-1, 34996-2, 34996-2-1, 34996; REF CCP-N3010: Lot Numbers: 34996-3, 34996-4, 34996-4-1, 34996; REF CCP-N3012: Lot Numbers: 34996-5, 34996-6, 34996-6-1, 34996; REF CCP-N3014: Lot Numbers: 10157-01, 34996-7, 34996-8, 34996-8-1, 34996; REF CCP-N3016: Lot Numbers: 34996-10, 34996-10-1, 34996-9, 34996; REF CCP-N3018: Lot Numbers: 34996-11, 34996-12, 34996-12-1, 34996; REF CCP-N3020: Lot Numbers: 34996-13, 34996-14, 34996-14-1, 34996; REF CCP-N3022: Lot Numbers: 34996-15, 34996-16, 34996-16-1, 34996; REF CCP-N3024: Lot Numbers: 34996-17, 34996-18, 34996-18-1, 34996; REF CCP-N3026: Lot Numbers: 34996-19, 34996-20, 34996-20-1, 34996; REF CCP-N3028: Lot Numbers: 34996-21, 34996-22, 34996-22-1, 34996; REF CCP-N3030: Lot Numbers: 34996-23, 34996-24, 34996-24-1, 34996; REF CCP-N3032: Lot Numbers: 34996-25, 34996-26, 34996-26-1, 34996; REF CCP-N3034: Lot Numbers: 34996-27, 34996-28, 34996-28-1, 34996; REF CCP-N3036: Lot Numbers: 34996-29, 34996-30, 34996-30-1, 34996; REF CCP-N3038: Lot Numbers: 34996-31, 34996-32, 34996-32-1, 34996; REF CCP-N3040: Lot Numbers: 34996-33, 34996-34, 34996; REF CCP-N3508: Lot Numbers: 1213, 34995-1, 34995-2, 34995; REF CCP-N3510: Lot Numbers: 0114, 34995-3, 34995-4, 34995; REF CCP-N3512: Lot Numbers: 0114, 34995-5, 34995-6, 34995; REF CCP-N3514: Lot Numbers: 0114, 34995-7, 34995-8, 34995; REF CCP-N3516: Lot Numbers: 0114, 34995-10, 34995-9, 34995;  REF CCP-N3518: Lot Numbers: 0114, 34995-11, 34995-12, 34995; REF CCP-N3520: Lot Numbers: 0114, 34995-13, 34995-14, 34995; REF CCP-N3522: Lot Numbers: 0114, 34995-15, 34995-16, 34995; REF CCP-N3524: Lot Numbers: 0114, 34995-17, 34995-18, 34995; REF CCP-N3526: Lot Numbers: 0114, 34995-19, 34995-20, 34995; REF CCP-N3528: Lot Numbers: 34995-21, 34995-22, 34995-22-1, 34995; REF CCP-N3530: Lot Numbers: 34995-23, 34995-24, 34995-24-1, 34995; REF CCP-N3532: Lot Numbers: 34995-25, 34995-26, 34995-26-1, 34995; REF CCP-N3534: Lot Numbers: 34995-27, 34995-28, 34995-28-1, 34995; REF CCP-N3536: Lot Numbers: 34995-29, 34995-30, 34995-30-1, 34995; REF CCP-N3538: Lot Numbers: 34995-31, 34995-32, 34995-32-1, 34995; REF CCP-N3540: Lot Numbers: 34995-33, 34995-34, 34995-34-1, 34995
  • Classification du dispositif
    Orthopedic Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Nationwide Distribution
  • Description du dispositif
    CrossCHECK Non-Locking Screw in the following sizes: 3.0 x 8 mm, REF CCP-N3008; 3.0 x 10 mm, REF CCP-N3010; 3.0 x 12 mm, REF CCP-N3012; 3.0 x 14 mm, REF CCP-N3014l; 3.0 x 16 mm, REF CCP-N3016; 3.0 x 18 mm, REF CCP-N3018; 3.0 x 20 mm, REF CCP-N3020; 3.0 x 22 mm, REF CCP-N3022; 3.0 x 24 mm, REF CCP-N3024; 3.0 x 26 mm, REF CCP-N3026; 3.0 x 28 mm, REF CCP-N3028; 3.0 x 30 mm, REF CCP-N3030; 3.0 x 32 mm, REF CCP-N3032; 3.0 x 34 mm, REF CCP-N3034; 3.0 x 36 mm, REF CCP-N3036; 3.0 x 38 mm, REF CCP-N3038; 3.0 x 40 mm, REF CCP-N3040; 3.5 x 8 mm, REF CCP-N3508; 3.5 x 10 mm, REF CCP-N3510; 3.5 x 12 mm, REF CCP-N3512; 3.5 14 mm, REF CCP-N3514; 3.5 x 16 mm, REF CCP-N3516; 3.5 x 18 mm, REF CCP-N3518; 3.5 x 20 mm, REF CCP-N3520; 3.5 x 22 mm, REF CCP-N3522; 3.5 x 24 mm, REF CCP-N3524; 3.5 x 26 mm, REF CCP-N3526; 3.5 x 28 mm, REF CCP-N3528; 3.5 x 30 mm, REF CCP-N3530; 3.5 x 32 mm, REF CCP-N3532; 3.5 x 34 mm, REF CCP-N3534; 3.5 x 36 mm, REF CCP-N3536; 3.5 x 38 mm, REF CCP-N3538; 3.5 x 40 mm, REF CCP-N3540. The CROSSCHECK Plating System is indicated for stabilization and fixation of fresh fractures, revision procedures, joint fusion and reconstruction of small bones in the hand, feet wrist and ankles, fingers and toes. The system may be used in both pediatric and adult patients. The device is intended for single use.
  • Manufacturer
    Wright Medical Technology, Inc.

Manufacturer

Wright Medical Technology, Inc.
  • Adresse du fabricant
    Wright Medical Technology, Inc., 1023 Cherry Rd, Memphis TN 38117-5423
  • Société-mère du fabricant (2017)
    Wright Medical Group NV
  • Source
    USFDA