Events

Rappel de Device Recall Stryker Reflex Hybrid Level Anterior Cervical Plate

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 Stryker Spine.

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
    50783
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1958-2009
  • Date de mise en oeuvre de l'événement
    2006-06-14
  • Date de publication de l'événement
    2009-08-20
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2009-08-20
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=77258
  • 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
    Appliance, fixation, spinal intervertebral body - Product Code KWQ
  • Cause
    Design flaw: the design did not prevent over angulation of the screws when the recommended instrument, all in one guide, was not used.
  • Action
    Stryker Spine issued an "Important Market Withdrawal" notice dated June 14, 2006. Consignees were advised to complete and return a Product Accountability Form via fax to 1-201-831-6069 prior to returning the affected product. Product return was to be performed during certain phase periods when upgrades were being shipped. For further questions, contact Stryker Spine at 1-201-831-5825.

Device

Device Recall Stryker Reflex Hybrid Level Anterior Cervical Plate
  • Modèle / numéro de série
    All Product with the following Catalog Number/Description: 48650112, Reflex Hybrid one-level plate, size 12mm; 48650114m size 14 mm; 48650116, 16 mm; 48650118, size 18mm; 48650120, size 20 mm; 48650122, size 22 mm.  48650224, Reflex Hybrid Two-Level Plate, size 24 mm; 48650226, size 26 mm; 48650228, size 28 mm; 48650230, size 30 mm; 48650232, size 32 mm; 48650234, size 34 mm; 48650237, size 37 mm; 48650240, size 40 mm; 48650243, size 43 mm; 48650246, size 46 mm. 48650339, REflex Hybrid Three-Level Plate, Size 39 mm; 48650342, size 42mm; 48650345, suze 45 mm; 48650348, size 48 mm; 48650351, size 51 mm; 48650354, size 54 mm; 48650357, size 57 mm; 48650360, size 60 mm; 48650363, size 63 mm; 48650366, size 66 mm; 48650369, size 69 mm. 48650460, Reflex Hybrid four-Level Plate, size 60 mm; 48650464, size 64 mm; 48650468, size 68 mm; 48650472, size 72 mm; 48650476, size 76 mm; 48650489, size 80 mm; 48650484, size 84 mm.
  • Classification du dispositif
    Orthopedic Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Nationwide Distribution -- Including states of NC, OR, AZ, TN, CA, MA, MD, IL, GA, FL, NJ, NM, KY, LA, PA, MI, UT, MO, OK, KS, OH, MN, NE, IN, MT, TX, AL, CO and WI.
  • Description du dispositif
    Stryker Reflex Hybrid Level Anterior Cervical Plate; || Non Sterile; Manufactured by Stryker Spine SAS, Cestas, France. Distributed by Howmedica Osteonics Corp. Mahwah, NJ 07430.
  • Manufacturer
    Stryker Spine

Manufacturer

Stryker Spine
  • Adresse du fabricant
    Stryker Spine, 2 Pearl Ct, Allendale NJ 07401-1611
  • Société-mère du fabricant (2017)
    Stryker
  • Source
    USFDA