Medical device manufacturer, Nobel Biocare, has issued a medical device safety alert concerning its NobelReplace (Tapered Drills, Dense Bone Drills, Screw Taps), Guided Start Drills/Counterbores and Guided Counterbores for NobelReplace, Implant Retrieval Instruments and Abutment Screw Retrieval Instruments. The affected devices distributed in Hong Kong are listed below:
On March 11, 2019, the manufacturer internally identified a packaging issue affecting the single-patient use drills for the affected products. It was discovered that the sealing process for blister packages performed by a supplier is ineffective; therefore, potentially compromising the sterility of the product. It cannot be guaranteed that the sterilized medical devices in scope of this recall remain sterile during their shelf-life.
The manufacturer has not received any complaints related to the issue described and is not aware of any illness or injury caused by the use of the devices and no incident reports have been submitted.
According to the manufacturer, affected batches were restricted on March 14, 2019. A Health Hazard Evaluation was performed, concluding on a high risk for the patient, i.e. a rare probability of permanent impairment. A recall was initiated to inform customers and remove affected devices in scope from the field.
The affected users are advised to take the following actions:
The manufacturer reviewed the packaging sealing process at the supplier site, has taken corrective actions and will initiate preventive actions to ensure a high level of safety and quality of the devices.
Product replacement is on-going.
According to the local supplier, the affected products are distributed in Hong Kong
If you are in possession of the products, please contact your supplier for necessary actions.
Posted on 29 March 2019