Neoss Guide – Drill-Hubs I to V included in Neoss Guide Kit 의 안전성 경고

Safety alert

2015-09-23

2015-09-23

Hong Kong

DH

https://www.mdco.gov.hk/english/safety/recalls/recalls_20150923c.html

Medical device safety alert: neoss guide – drill-hubs i to v included in neoss guide kit the therapeutic goods administration (tga) of australia has posted a medical device safety alert concerning neoss guide – drill-hubs i to v included in neoss guide kit ø3.5 - ø4.5 (art number 51153), manufactured by neoss. the affected product identifier is 9040, with product numbers (bn) 15182, 15586 and 16030. according to the alert, the affected batches of drill-hub i may not be functioning as intended. specifically, the drill does not latch completely in the drill-hub i. the upper part of the bore in the drill-hub i is slightly smaller which results in the drill not being seated correctly which means that this drill-hub will drill deeper than intended, this could lead to permanent damage of the alveolar nerve and cause permanent loss of sense in parts of the oral cavity or chin or even partial loss of speech. there is also a risk of drill loosening or not rotating as expected. the manufacturer advises affected users to inspect their stock on hand and to quarantine affected units prior to their return to the manufacturer. for details, please refer to the tga websites:http://apps.Tga.Gov.Au/prod/sara/arn-detail.Aspx?k=rc-2015-rn-00917-1 if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 23 september 2015.