Medical device manufacturer, Nobel Biocare, has issued a medical device safety alert concerning its Abutment Retrieval Instrument [Zirconia CC RP/WP] and Kit [Product numbers: 37882 and 37508; Lot number: 96149].
The manufacturer received a complaint regarding the Abutment Retrieval Instrument that the abutment / metal adapter could not be removed together with the retrieval instrument from the implant as intended due to the incorrect functional length of the shell.
Since the retrieval instrument was used to ease a procedure, the degree of seriousness of the health hazard was judged by the manufacturer as very low. Besides, if the retrieval instrument did not work, a tweezers or other instrument could be used to remove the metal adapter.
Product recall is ongoing.
According to the manufacturer, 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 22 June 2015