Events

Alerte De Sécurité sur Midface Distractor, complete, distraction length 40 mm, Titanium Alloy (TAN)

Selon Department of Health, ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Hong Kong qui a été fabriqué par Synthes GmbH.

Qu'est-ce que c'est?

Les alertes fournissent des informations importantes et des recommandations concernant les dispositifs médicaux. Le fait qu'une alerte soit émise ne signifie pas nécessairement qu'un dispositif soit dangereux. Les alertes de sécurité, qui sont envoyées tant aux travailleurs du secteur médical qu'aux utilisateurs de ces dispositifs, peuvent inclure des rappels. Elles peuvent être rédigées par des fabricants mais aussi par des autorités en charge de la santé.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert
  • Date
    2014-01-22
  • Date de publication de l'événement
    2014-01-22
  • Pays de l'événement
    Hong Kong
  • Source de l'événement
    DH
  • URL de la source de l'événement
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20140122a.html
  • Notes / Alertes
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
  • Notes supplémentaires dans les données
    Medical Device Safety Alert
  • Cause
    Medical device safety alert: synthes gmbh midface distractor, complete, distraction length 40 mm, titanium alloy (tan) medical device manufacturer, synthes gmbh, has issued a field safety notice concerning midface distractor, complete, distraction length 40 mm, titanium alloy (tan) (part number: 487.982; lot number: prior to 6913910). as the tab of some distractors may be oversized, there is the potential for the anterior footplates not to fit onto the midface distractor assembly (part number 487.982). because recognition of the defined defect may not be detected until the intraoperative patient treatment period, there is the potential that the index surgical goals will not be achieved and a second unanticipated surgical intervention would be required. according to the manufacturer, there have been no adverse events associated with this issue. the manufacturer advises users to quarantine and return all unused affected products. according to the local supplier, the affected products were distributed in hong kong. if you are in possession of the products, please contact your supplier for necessary actions. posted on 22 january 2014.

Device

Midface Distractor, complete, distraction length 40 mm, Titanium Alloy (TAN)
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Synthes GmbH Midface Distractor, complete, distraction length 40 mm, Titanium Alloy (TAN)
  • Manufacturer
    Synthes GmbH

Manufacturer

Synthes GmbH