Important Safety Alerts

Medical device manufacturer, Nobel Biocare, has issued a medical device safety alert concerning its Titanium abutments. The affected products are identified as follow:

• Product: A) Temporary Abutment Non-Engaging CC RP; B) Temporary Abutment Engaging CC RP; C) Esthetic Abutment CC RP 1.5mm; D) Snappy Abutment 5.5 CC RP 3mm; E) Universal Base CC RP 1.5mm; F) Temporary Snap Abut Eng CC RP 1.5mm
• Product Number: A) 36662; B) 36664; C) 36669; D) 36683; E) 38214; F) 38761
• Lot Number: A) 13078005; B) 13077622; C) 13077560; D) 13077700; E) 13076822; F) 13077550, 13077551

According to the manufacturer, packages of affected abutment lots may contain an incorrect screw. The screw will tighten, however it cannot be guaranteed that the screw will not loosen. In case the screw loosens the abutment should be retightened with the correct screw.

Affected users are advised to identify the affected lots and do not use the devices. Product replacement is on-going.

If you are in possession of the products, please contact your supplier for necessary actions.

Posted on 9 August 2019