Medical device manufacturer, Nobel Biocare, has issued a medical device safety alert concerning its Healing Abutment Conical Connection RP Ø 3.6 x 5 mm [Catalogue number: 36644; Lot number: 13076845; Manufacturing date: 20 January 2019; Expiration date: 19 December 2021].
On 23 April 2019, a customer in the United States (US) returned ten packages of the affected products [labeled 36644 (Healing Abutment CC RP Ø3.6x5mm), lot 13076845], stating the packages contain an incorrect healing abutment. Inspection performed by the manufacturer confirmed that all ten packages contain article 33452 (Healing Abutment NobRpl RP Ø5.3x5mm), lot 13076868.
Investigation concluded that 239 pieces of article 36644, lot 13076845 were manufactured and 16 pieces of article 33452, lot 13076868 were incorrectly labeled as article 36644, lot 13076845. An extra label sheet (including 16 individual labels) had been printed for the complained lot 13076845. Instead of the sheet being scrapped, it was in error used on article 33452, lot 13076868.
According to the manufacturer, the Health Hazard Evaluation was performed concluding on a high risk for the patient: a misfit between the abutment and the implant could potentially lead to inflammation or damage to the implant due to increased forces on the implant threads. Both issues could result in a need for revision surgery.
The manufacturer is not aware of any illness or injury caused by the issue.
Product removal is implemented.
According to the local supplier, the affected products are not distributed in Hong Kong.
If you are in possession of the products, please contact your supplier for necessary actions.
Posted on 29 May 2019