Events

Rappel de Device Recall Xcelerate Specialty Patella Milling System

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 Howmedica Osteonics Corp..

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
    57852
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1862-2011
  • Date de mise en oeuvre de l'événement
    2011-01-27
  • Date de publication de l'événement
    2011-03-31
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-10-15
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=97584
  • 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
    Gauge, depth - Product Code HTJ
  • Cause
    Stryker orthopaedics has become aware that the 10 mm on the bone remaining depth gage is incorrect thus allowing for the reamer to leave as little as 8.9mm (in a nominal condition) patella bone.
  • Action
    Stryker sent an Urgent Product Recall letter dated January 27, 2011, via FedEX for January 28, 2011, delivery with return receipt. The letter identified the product, the problem, and the action to be taken by the customer. Customers were insructed to fax back the attached Product Recall Acknowledgement Form within 5 days to 201-831-6069. Customers were also instructed to contact the hospitals in their territory that have the affected product to arrange return of the product. Product should be returned to the attention of: Regulatory Compliance Stryker Orthopaedics 325 Corporate Drive Mahwah, New Jersey, 07430. The orange Product Remediation sticker should be attached to the return, indicating the Product Remediation # RA 2009-296. Mark the outer box with words "Product Recall." For questions regarding this recall call (201) 972-2100.

Device

Device Recall Xcelerate Specialty Patella Milling System
  • Modèle / numéro de série
    All lots
  • Classification du dispositif
    Orthopedic Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide Distribution
  • Description du dispositif
    Xcelerate Specialty Patella Milling System Per File K2399; Catalog Number I-K2399PR00, I-K2399PR10; Stryker Howmedica Osteonics, Howmedica Osteonics Corp., 325 Corporate Drive, Mahwah, NJ 07430 || The Xcelerate patella milling system (as detailed in surgical protocol LSPK35) was designed to prepare a patella to accept all Scorpio or Duracon patellar implants using either a resurfacing or recessed technique.
  • Manufacturer
    Stryker Howmedica Osteonics Corp.

Manufacturer

Stryker Howmedica Osteonics Corp.
  • Adresse du fabricant
    Stryker Howmedica Osteonics Corp., 325 Corporate Drive, Mahwah NJ 07430
  • Société-mère du fabricant (2017)
    Stryker
  • Source
    USFDA