Events

Alerte De Sécurité sur 17° Multi-Unit Abutment CC NP 2.5mm

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

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
    2018-03-19
  • Date de publication de l'événement
    2018-03-19
  • 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_20180319a.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: nobel biocare 17° multi-unit abutment cc np 2.5mm medical device manufacturer, nobel biocare production ab, has issued a medical device safety alert concerning its 17° multi-unit abutment cc np 2.5mm [article number: 36614; lot number: 12070802; manufacturing date: 29 august, 2016; expiry date: 29 july, 2019]. the manufacturer’s quality management system has detected that a few parts of the affected product carry a product label where parts of the mandatory information, e.G. lot number and expiry date, are missing. except for this missing information all products within this lot are according to specification and safe to use. according to the manufacturer, the root cause is most likely related to an intermittent error in the transmission of data from the labelling system to the label printers. lacking information regarding expiry date, single use and sterility might lead to usage of products beyond the shelf life which might lead to infections that might affect the osseointegration of the connected implant. the missing lot number information might also cause issues regarding the traceability of the affected product to the patient on a clinician/patient level. the parts with a correct label, i.E. the retention sample, is confirmed correct. no significant public health impact beyond the users is foreseen with this issue. the affected user is advised to return the affected product to the manufacturer for replacement. according to the local supplier, the affected product is distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 19 march 2018.

Device

17° Multi-Unit Abutment CC NP 2.5mm
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Nobel Biocare 17° Multi-Unit Abutment CC NP 2.5mm
  • Manufacturer
    Nobel Biocare production AB

Manufacturer

Nobel Biocare production AB