TFNA Helical-Blade Impactor 의 안전성 경고

Safety alert

2015-06-19

2015-06-19

Hong Kong

DH

https://www.mdco.gov.hk/english/safety/recalls/recalls_20150619a.html

Medical device safety alert: synthes gmbh tfna helical-blade impactor medical device manufacturer, synthes gmbh, has issued a medical device safety alert concerning its tfna helical-blade impactor [part number: 03.037.024; lot number: t102762]. the manufacturer has initiated a voluntary medical device recall of one lot of the tfna helical-blade impactor of the tfn-advancedtm proximal femoral nailing system. the tfna system is intended for treatment of proximal femoral fractures. the height of one of the three guiding pins of the tfna helical-blade impactor may potentially be oversized. if the guiding pin were to be oversized, the tfna helical-blade impactor (part number 03.037.024) would not be able to pass through the guide sleeve (part number 03.037.017). if the tfna helical-blade impactor is not able to pass through the guide sleeve, there is the potential for surgical delay while an alternative trauma set is located to complete the procedure. according to the local supplier, the affected products are distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 19 june 2015.