Events

Rappel de Device Recall Rotate, BulletTip, TPlus, Contact, Crossfuse, and CrossFuse II, Interbody Fusion/Vertebral Body Re

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 RTI Surgical, Inc. (dba Pioneer Surgical 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
    71424
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1916-2015
  • Date de mise en oeuvre de l'événement
    2015-05-21
  • Date de publication de l'événement
    2015-06-26
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2015-10-29
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=137744
  • 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
    Intervertebral fusion device with bone graft, lumbar - Product Code MAX
  • Cause
    Three lots of the bullet -tip vbr 13mm x 32 mm implants are mislabeled with a light green colored label, used for 16 mm trial instead of a lime green label, used for a 13 mm trial.
  • Action
    RTI Surgical sent an" Urgent Medical Device Voluntary Recall " Notification dated May 21, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Immediate Actions: We are aware that one of this product was distributed to you. This one device has already been returned to RTI Surgical so no further action is needed. This notice is for your records. RTI takes this error seriously and has initiated a corrective and preventative action investigation to prevent recurrence. We apologize for any inconvenience this may have caused. For further questions please call (906) 226-4489.

Device

Device Recall Rotate, BulletTip, TPlus, Contact, Crossfuse, and CrossFuse II, Interbody Fusion/V...
  • Modèle / numéro de série
    Part Number: 32-13-32 Lot: 200827 Expiration Date: 2019-12-18 Part Number: 30-T-13-6 Lot: 202726 Expiration Date: 2020-01-16  Part Number: 30-T-1036-13-6 Lot: 202582 Expiration Date: 2020-01-15
  • Classification du dispositif
    Orthopedic Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    US Distribution to the states of : FL and NY
  • Description du dispositif
    Bullet-Tip PEEK VBR/IBF System, 32mm(l) 13mm(H) Implant 32-13-32 UDI (01)008464680341 08(17)191218(10)200827; T-Plus PEEK VBR/IBF System, 10mm(W) x 27mm(l) x 13mm(H) Implant, 6degree lordotic 30-T-13-6 UDI (01) 00846468032920(17) 200116(10) 202726; and T-Plus PEEK VBR/IBF System, 10mm(W) x 36 mm(l) x 13mm(H) Implant, 6degree lordotic 30-T-1036-13-6 UDI (01)00846468032760(17)200115(10)202582. These products are part of the lnterbody Fusion Vertebral || Body Replacement System to ensure stability of the spine and adequate compression of the implant.
  • Manufacturer
    RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)

Manufacturer

RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)
  • Adresse du fabricant
    RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.), 375 River Park Cir, Marquette MI 49855-1781
  • Société-mère du fabricant (2017)
    RTI Surgical Inc
  • Source
    USFDA