Events

Rappel de Device Recall First Choice Partial Ulnar Head System ("DRUJ 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 Ascension Orthopedics, 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
    60855
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1060-2012
  • Date de mise en oeuvre de l'événement
    2011-12-03
  • Date de publication de l'événement
    2012-02-17
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2013-01-14
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=106650
  • 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
    Prosthesis, wrist, hemi-, ulnar - Product Code KXE
  • Cause
    A recent review conducted by ascension orthopedics revealed that certain modifications were made to the first choice system and should have been preceded by a submission of a filing with the fda.
  • Action
    The Firm, Ascension Orthopedics, sent an "URGENT: MEDICAL DEVICE RECALL" letter dated December 3, 2011 via FedEx, email or fax to all customers. The letter described the product, problem, and actions to be taken. The customers were instructed to immediately cease any further use of any affected product; remove from their stockrooms until it is shipped back to Ascension Orthopedics; promptly return any affected product to: Ascension Orthopedics, 8700 Cameron Road, Austin, TX 78754, Attn: First Choice DRUJ Recall Administrator, and complete and return the reply form even if you do not have affected product in stock, to Regulatory Affairs Dept. via fax to 512-836-6933. If you have any questions, please do not hesitate to contact customer service at 1-512-836-5001.

Device

Device Recall First Choice Partial Ulnar Head System ("DRUJ System").
  • Modèle / numéro de série
    This recall applies to all of the First Choice DRUJ Partial Ulnar Head Devices. All lot numbers of the following Catalog Numbers are included:  DRUJ-610-1445-WW, DRUJ-610-1455-WW, DRUJ-610-1465-WW,  DRUJ-610-1645-WW,  DRUJ-610-1655-WW,  DRUJ-610-1665-WW,  DRUJ-610-1745-WW,  DRUJ-610-1755-WW,  DRUJ-610-1765-WW,  DRUJ-610-1945-WW,  DRUJ-610-1955-WW, and  DRUJ-610-1965-WW.
  • Classification du dispositif
    Orthopedic Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Worldwide distribution.
  • Description du dispositif
    Ascension Orthopedics First Choice Partial Ulnar Head System ("DRUJ System"). Head sizes 14.5 mm, 16.0 mm, 17.5 mm, and 19.0 mm each with stem sizes 4.5 mm, 5.5 mm, or 6.5 mm. || The First Choice DRUJ System is intended for replacement of the distal radio-ulnar joint. The Partial Head implant is indicated for replacement of the distal ulnar head for rheumatoid, degenerative, or post-traumatic arthritis
  • Manufacturer
    Ascension Orthopedics, Inc

Manufacturer

Ascension Orthopedics, Inc