Important Safety Alerts

Medical device manufacturer, Nobel Biocare USA, LLC, has issued a medical device safety alert concerning its NobelReplace CC PMC RP 4.3x10mm endosseous dental implant [Catalog Number: 37291, Lot Number: 13084072, Manufacturing Date: 27 June 2019, Expiration Date: 25 May 2024].

The manufacturer received a complaint from a customer in Hong Kong stating that the cap label for the affected product is different from the vial label on side of the vial. Inspection of the complaint sample confirmed that the cap label incorrectly states 5.0x8mm while the vial label shows the correct measurements of 4.3x10mm.

If the incorrect measurements are not noticed prior to implant placement, the following potential hazards are foreseen:

• A second surgical procedure may be required to complete the treatment with the correct size implant.
• Implant replacement surgery may be required if the incorrect length is discovered after the implant had been placed.
• While considered unlikely, if placed in the posterior lower jaw, the implant may damage the inferior alveolar nerve canal or perforate a small artery requiring immediate removal of the implant.

Affected users are advised to quarantine the affected products and return all incorrectly labeled products to the manufacturer.

The manufacturer has reviewed the packaging and labeling processes, implemented corrective actions and will initiate preventive actions to ensure a high level of safety and quality of its medical devices. Product recall is on-going.

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 17 July 2020