Events

Alerte De Sécurité sur CORAIL AMT Neck Trials Surgical Instruments

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

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
    2018-05-29
  • Date de publication de l'événement
    2018-05-29
  • 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_20180529.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: depuy synthes corail amt neck trials surgical instruments medical device manufacturer, depuy synthes, has issued a medical device safety alert concerning its corail amt neck trials surgical instruments. the affected devices are identified as below: part description: a) corail amt neck seg 135d short; b) corail amt neck seg 135d kho; c) corail amt neck seg 135d std; d) corail amt neck seg 125d kla; e) corail amt neck seg 125d std part number: a) l94007; b) l94006; c) l94005; d) l94004; e) l94003 lot number: all lot the manufacturer addressed the potential for debris/material to be found behind the o-rings for some corail neck trials. according to the manufacturer, twelve complaints were received related to debris behind the o-ring. it has evaluated the issue and determined that none of these complaints have resulted in patient harm and found no increased risk to the patients. as a precautionary measure, the manufacturer determined that reworking the affected devices and removing the o-rings is the appropriate corrective action. the function of the device is unaffected by this change as the manufacturer currently markets products of the same design (i.E. without an o-ring). the affected users are advised to take the following actions: continue to follow the instructions for use in ifu-w90946 rev b regarding cleaning of these devices; medical facilities are to determine if any of the affected instruments are on hand, and contact their sales consultant to arrange for rework or replacement of these instruments; notify surgeons at their facility by providing them with a copy of the notice to ensure surgeons are aware of the field safety notice. according to the local supplier, the affected product part number: l94007, is distributed in hong kong. if you are in possession of the affected product, please contact your supplier for necessary actions. posted on 29 may 2018.

Device

CORAIL AMT Neck Trials Surgical Instruments
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: DePuy Synthes CORAIL AMT Neck Trials Surgical Instruments
  • Manufacturer
    DePuy Synthes

Manufacturer

DePuy Synthes