Events

Rappel de Device Recall BLACKSTONE PILLAR SA PARTIAL VERTEBRAL BODY REPLACEMENT DEVICE

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 Orthofix, 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
    53968
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0641-2010
  • Date de mise en oeuvre de l'événement
    2009-11-19
  • Date de publication de l'événement
    2010-01-15
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2010-02-02
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=86980
  • 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 MQP
  • Cause
    The pillar sa implant insertion instrument 49-1100 may experience resistance in turning the activation knob while releasing an implant after intra-operative positioning.
  • Action
    A notification letter dated November 19, 2009 was sent to customers via Federal Express. The letter described the recalled product (PILLAR SA Implant Insertion Instrument, 49-1100) and problem and actions for customers to take. The affected product, PILLAR SA lmplant lnsertion lnstrument, 49-1100 is in the PILLAR SA set (set part number 49-0021) which was shipped to customers. An enclosed attachment provide instructions on product removal and return. Customers were instructed to complete the enclosed Tracking and Verification Form and fax to Orthofix Spinal Implants at 1-973-406-2912. A replacement instrument will be provided as available. In the interim, the Implant Inserter (Part Number 49-1000) included in the PILLAR SA UPE set (set number 49-0020) that was provided earlier this year may be used as an alternative to the affected product. For questions regarding the removal and return of the recalled product to Orthofix Spinal Implants, please contact your Account Services Representative. Direct other questions to the Regulatory Affairs Department at 1-973-406-2812. Direct product questions to Marketing at 1-862-221-1335 or Product Development at 1-973-406-2824.

Device

Device Recall BLACKSTONE PILLAR SA PARTIAL VERTEBRAL BODY REPLACEMENT DEVICE
  • Modèle / numéro de série
    Part number: 49-1100, Lot Number 17301-L125.
  • Classification du dispositif
    Orthopedic Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    United States (IA, NV, CO, AZ, NY, MD, IL, VA, MN, MI, NC, CT, LA, AR, GA, CA, MO, WA, OK and AL).
  • Description du dispositif
    Orthofix Spinal Implants; Pillar SA PEEK Spacer System Instrument Case. || Case contents: Implant Insertion Instrument, Straight Tamp, Bone Awl Drill Guide, Straight Drill, U-Joint Driver with and without retention, Flex Shaft Driver, Trial Insertion Instrument, Drill Tips, Cover Plate Inserter, Cover Plate Driver, Cover Plate Holder, Ratcheting Handle, Torque Limiting Handle, Hex Driver, Distractors/Sizers, Sizers REF: 49-0021: Orthoflex Spinal Implants, 1211 Hamburg Tnpk, Suite 300, Wayne, NJ 07470. || The Pillar SA Implant Insertion Instrument is intended for intraoperative use in placing/inserting Pillar SA implants into a prepared interbody space.
  • Manufacturer
    Orthofix, Inc

Manufacturer

Orthofix, Inc
  • Adresse du fabricant
    Orthofix, Inc, 1720 Bray Central Dr, McKinney TX 75069-8207
  • Société-mère du fabricant (2017)
    Orthofix International Nv
  • Source
    USFDA